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PMA Final Decisions for July 2011

Wed, 09/28/2011 - 9:30am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P100001

7/20/11

VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, VITROS Immunodiagnostic Products Anti-HBe Calibrator, VITROS Immunodiagnostic Products Anti-HBe Controls Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Approval for the VITROS Immunodiagnostic Products Anti-HBe Reagent Pack, Calibrator and Controls. This device is indicated for:

VITROS Immunodiagnostic Products Anti-HBe Reagent Pack - For the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe) in human adult and pediatric (2 to 21 years old) serum from individuals who have symptoms of chronic hepatitis and those who have recovered from HBV infection, using the VITROS ECi/ECiQ Immunodiagnostic Systems. Further assessment of HBV infection (biochemical, serological and/or nucleic acid testing) is required to define the specific disease state. VITROS Anti-HBe test performance has not been established for the monitoring of HBV disease or therapy.

VITROS Immunodiagnostic Products Anti-HBe Calibrator - For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems when used

with the VITROS Anti-HBe test for the in vitro qualitative detection of antibodies to hepatitis B e antigen (anti-HBe). VITROS Immunodiagnostic Products Anti-HBe Controls - For use in monitoring the performance of the VITROS Anti-HBe test when used on the VITROS ECi/ECiQ Immunodiagnostic Systems.

P110001

7/20/11

RX Herculink Elite Renal Stent System Abbott Vascular

Temecula, CA

92592

Approval for the RX Herculink Elite Renal Stent System. This device is indicated for use in patients with atherosclerotic disease of the renal arteries following sub-optimal percutaneous transluminal renal angioplasty (PTRA) of a de novo or restenotic atherosclerotic lesion (≤ 15 mm in length) located within 10 mm of the renal ostium and with a reference vessel diameter of 4.0 - 7.0 mm. Suboptimal PTRA is defined as ≥ 50% residual stenosis, ≥ 20 mmHg peak systolic or ≥ 10 mmHg mean translesional pressure gradient, flow-limiting dissection, or TIMI [Thrombolysis In Myocardial Infarction] flow < 3.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18286/S021

7/9/11

Real-Time

Gelfoam (absorbable gelatin) Sterile Sponge Pfizer, Inc.

New York, NY

10017

Approval for a change in some of the components contained in the Gelfoam Plus Kit as well as the introduction of an alternative Gelfoam Plus Kit – Gelfoam Plus compressed. The component changes will substitute prefilled saline syringes and a needleless transfer device for the standard saline vials and needle-syringe. The components have been cleared/ approved previously. The purpose of the Gelfoam Plus Kit is to provide the convenience of co-packaged collagen sponge, saline diluent and Human Thrombin to a physician during surgery.
P810002/S074

7/18/11

135-Day

Masters Valved Graft St. Jude Medical, Inc. Approval for change to the sterilization load and configuration.
P830055/S118

7/1/11

135-Day

LCS Total Knee System DePuy Orthopedics, Inc.

Warsaw, IN

46581

Approval for a change to a new drag finishing process at the Cork, Ireland facility.
P860003/S057

7/29/11

180-Day

THERAKOS CELLEX Photopheresis System Therakos, Inc.

Raritan, NJ

08869

Approval for software changes to the THERAKOS CELLEX Photopheresis System.
P860004/S123

7/29/10

Real-Time

The Guidewire Accessory for Intrathecal Catheters Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for the Changes to the Guidewire Accessory for Intrathecal Catheter Models 8731SC and 8598A.
P860004/S130

7/1/11

180-Day

The Battery for the SynchroMed II Medtronic Neuromodulation Minneapolis, MN 55432 Approval for design changes to the Battery for the SynchroMed II Model 8637 Programmable Drug Infusion System.
P860057/S071

7/26/11

180-Day

Carpentier-Edwards Magna Mitral Pericardial Bioprosthesis Edwards Lifesciences, LLC

Irvine, CA

92614

Approval of the post-approval study protocol.
P860057/S072

7/27/11

135-Day

Carpentier-Edwards PERIMOUNT Pericardial Bioprosthetic Valves Edwards Lifesciences, LLC Irvine, CA

92614

Approval for an alternate supplier for Atex Bias Cloth.
P870056/S040

7/27/11

135-Day

Carpentier-Edwards Porcine Bioprosthetic Valves Edwards Lifesciences, LLC Irvine, CA

92614

Approval for an alternate supplier for Atex Bias Cloth.
P880086/S193

7/25/11

180-Day

Affinity/Integrity/ Victory/Verity/ Zephyr and Accent Family of Pacemakers St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P880086/S205

7/22/11

Real-Time

Sustain XL Family of Pacemakers St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).
P890003/S226

7/1/11

Real-Time

Consulta CRT-P and Syncra CRT-P Implantable Devices Medtronic, Inc. Mounds View, MN 55112 Approval of modification to the “2490G Software Requirements Specification” to add the CRT-P device model numbers to the Auto-ID list for the Model 2020A CardioSight Reader.
P910001/S045

7/14/11

135-Day

ELCA Coronary Atherectomy Catheters Spectranetics Corporation

Colorado Springs, CO

80921

Approval for changes to pyrogen testing procedures and sampling.
P910007/S021

7/26/11

180-Day

ARCHITECT Total PSA Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd in Singapore.
P910007/S029

7/22/11

180-Day

ARCHITECT Total PSA Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P920047/S046

7/27/11

135-Day

Blazer II & Blazer Prime HTD Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for an alternate sterilization cycle.
P920047/S047

7/19/11

180-Day

Blazer II/Prime HTD Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P930031/S029

7/19/11

135-Day

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a component vendor facility site change.
P940019/S024

7/19/11

135-Day

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a component vendor facility site change.
P950022/S074

7/25/11

180-Day

Passive Fixation sj4 Leads St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P950024/S017

7/29/11

180-Day

CapSure EPI Unipolar and Bipolar Leads Medtronic, Inc.

Mounds View, MN

55112

Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co. in Villalba, Puerto Rico.
P950037/S062

7/1/11

135-Day

Selox SR/St/JT, Setrox S and Dextrus Steroid-Eluting Leads Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P960013/S062

7/25/11

180-Day

Tendril, Tendril ST, Tendril STS and Optisense Leads St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P960030/S032

7/25/11

180-Day

Passive Plus, Isofles S&P and Isoflex Optim Leads St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P960042/S027

7/14/11

135-Day

Spectranetics Laser Sheath II Spectranetics Corporation

Colorado Springs, CO

80921

Approval for changes to pyrogen testing procedures and sampling.
P970003/S130

7/29/11

Real-Time

VNS Therapy System – Programming Software Cyberonics, Inc.

Houston, TX

77058

Approval for a modification to the Serial Adapter Cable Power Connector.
P970013/S036

7/25/11

180-Day

Microny Family of Pacemakers St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P970018/S023

7/15/11

Special

BD Prepstain System Tripath Imaging Inc. (dba BD Diagnostics)

Durham, NC

27703

Approval for vacuum pump safety hazard labeling changes.
P980003/S028

7/27/11

135-Day

Chilli II Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for an alternate sterilization cycle.
P980003/S029

7/19/11

Real-Time

Chilli® Cooled Ablation System – Electrophysiology Cables Boston Scientific Corporation

San Jose, CA

95134

Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P980007/S013

7/26/11

180-Day

ARCHITECT Free PSA Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd in Singapore.
P980007/S020

7/22/11

180-Day

ARCHITECT Free PSA Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P980023/S034

7/1/11

135-Day

Kentrox SL/SL-S/RV/RV-S and Linox S/SD/T/TD Steroid-Eluting Leads Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P980033/S018

7/19/11

135-Day

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for a component vendor facility site change.
P980037/S036

7/19/11

Real-Time

AngioJet® Rheolytic™ Thrombectomy System MEDRAD Interventional/

Possis

Minneapolis, MN

55433

Approval for modifications to the Ultra Console to make it more robust to fluid ingress.
P980041/S013

7/1/11

180-Day

Access AFP Assay On the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the following modifications made to the Access, Synchron and UniCel families of instrumentation platforms: 1) modification of the occlusion bracket on the Access and UniCel instruments; 2) revision of the UniCel system software; 3) redesign of the sample probe tube assembly; and 4) new information regarding potential interferents of AFP measurement due to the presence of immunosuppressant drugs prescribed to pregnant women.
P990019/S007

7/7/11

Real-Time

BLU-U® Blue Light Photodynamic Therapy Illuminator DUSA

Pharmaceuticals, Inc.

Wilmington, MA

01887

Approval for a software change to eliminate the need to artificially limit the cycle lifetime for the BLU-U treatment lamp system.
P000007/S025

7/27/11

135-Day

Edwards Porcine Stentless Bioprosthetic Valve Edwards Lifesciences, LLC Irvine, CA

92614

Approval for an alternate supplier for Atex Bias Cloth.
P000008/S024

7/29/11

Special

LAP-BAND® Adjustable Gastric Banding (LAGB) System Allergan

Goleta, CA

93117

Approval to modify the Directions for Use for the RapidPort EZ Port Applier, an accessory to the LAP-BAND System, to clarify the proper method of holding the RapidPort EZ Port Applier and how to apply pressure to the Port Applier to ensure the correct positioning of the access port.
P000025/S050

7/22/11

180-Day

MED-EL COMBI 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Approval for an updated version of the MED-EL COMBI 40+ Cochlear Implant

System referred to as MAESTRO 2010 consisting of the following features: 1) a thinner version of the SONATATi- 100 cochlear implant, the MED-EL CONCERT;

2) several design and manufacturing updates related to the introduction of the MEDEL CONCERT; 3) new tasks and functionalities added to the MAESTRO fitting software; 4) a selection of new colors available for the OPUS 2 audio processor and; 5) a new, more energy-efficient, audio processor coil.

P000025/S052

7/22/11

Real-Time

Combi 40+ Cochlear Implant System MED-EL Corporation

Durham, NC

27713

Approval for introduction of the Mini Battery Pack, an optional external battery pack to be used to power the TEMPO+, OPUS 1, and OPUS2 audio processors.
P010014/S031

7/29/11

Real-Time

Oxford® Partial Knee System Biomet, Inc. Approval for labeling changes to the surgical technique brochure for the Oxford® Partial Knee System that include the addition of instructions for use for the Signature™ Personalized Patient Care System (patient-matched cutting/drilling guides.)
P010015/S125

7/1/11

Real-Time

Consulta CRT-P and Syncra CRT-P Implantable Devices Medtronic, Inc. Mounds View, MN 55112 Approval of modification to the “2490G Software Requirements Specification” to add the CRT-P device model numbers to the Auto-ID list for the Model 2020A CardioSight Reader.
P010023/S009

7/15/11

135-Day

MAXUM System Ototronix, LLC

St. Paul, MN

55110

Approval of a manufacturing process and supplier change to the Magnet Canister Assembly.
P010030/S027

7/15/11

Real-Time

WCD 3000,

WCD 3000S,

WCD 3100 and WCD 4000

Zoll Lifecor Corporation

Pittsburgh, PA 15238

Approval for the minor hardware (components) changes due to the RoHS requirements for the components of the devices.
P010030/S028

7/7/11

Real-Time

LifeVest® Wearable Defibrillator Zoll Lifecor Corporation

Pittsburgh, PA

15238

Approval for use of the E-One Moli Energy IHR18650B (2.25Ah) Lithium-Ion battery cell with your LifeVest® Model 4000 Wearable Defibrillator.
P020014/S034

7/1/11

180-Day

Conceptus Essure® System for Permanent Birth Control Conceptus, Inc.

Mountain View, CA

94041

Approval to remove a contraindication and to revise a warning regarding nickel sensitivity in physician’s labeling.
P020025/S027

7/27/11

135-Day

Blazer II XP and Blazer Prime XP Catheters Boston Scientific Corporation

San Jose, CA

95134

Approval for an alternate sterilization cycle.
P020025/S028

7/19/11

Real-Time

Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables Boston Scientific Corporation

San Jose, CA

95134

Approval for packaging design change for the Blazer II/Prime HTD Catheters – Electrophysiology Cables, Models M0046130 and M0046510; Chilli® Cooled Ablation System – Electrophysiology Cables, Models M0046810 and M004620620; and Blazer II XP and Blazer Prime Cardiac Ablation Catheters – Electrophysiology Cables, Models M0046130 and M0046510.
P020045/S037

7/15/11

Real-Time

Freezor Cardiac CryoAblation Catheters, Freezor Xtra and Freezor MAX Surgical CryoAblation Devices and CCT.2 CryoConsole System Medtronic CryoCath LP

Quebec, Canada

Approval for sterilization and packaging changes.
P030025/S093

7/25/11

180-Day

TAXUS ® Express 2® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation

Maple Grove, Mn 55311

Approval for labeling changes to update the directions for use to include additional data from the TAXUS VISR study.
P030032/S012

7/18/11

Real-Time

PREVELLE Silk Genzyme Biosurgery

Cambridge, MA

02142

Approval for changes in the methods and specifications for testing the PREVELLE Silk final product (i.e., 1) changing the "Average Extrusion Force" specification

from less than 80N to an "Average of Average Extrusion Force" specification of less than 40N;

2) changing the "Maximum Peak Extrusion Force" specification of less than 100N to an

"Average of Maximum Peak Extrusion Force" specification of less than 50N; and 3) changing the

method of determining the "Maximum Peak Extrusion Force" specification from the highest single value observed in 10 samples to an "Average of the Maximum Peak Extrusion Force" test

results observed in 25 samples).

P030035/S073

7/25/11

180-Day

Frontier/Frontier II Family of CRT-PS St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P030035/S085

7/22/11

Real-Time

Promote/Frontier Family of Pacemakers St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for a change to the seal plug for the setscrew (referred to as the septum in the submission).
P030054/S168

7/25/11

180-Day

Epic HF/Atlas+ HF Family of CRT-DS St. Jude Medical Sunnyvale, CA

94086

Approval for a manufacturing site located at St. Jude Medical Operations (My) Sdn. Bhd. in Bayan Lepas, Malaysia.
P040012/S036

7/28/11

135-Day

Acculink Carotid Stent System Abbott Vascular, Inc.

Santa Clara, CA

95054

Approval for changes to your solution manufacturing process.
P040024/S050

7/1/11

135-Day

Restylane Injectable Gel Medicis Pharmaceutical Corporation Approval for a change in the composition of the biological indicator used for qualification and requalification of the steam sterilization procedure.
P040024/S052

7/18/11

180-Day

Restylane Injectable Gel Medicis Aesthetics Holding, Inc.

Scottsdale, AZ

85256

Approval for an extension to the expiration date of the lidocaine hydrochloride raw material from 12 months to 24 months.
P040044/S038

7/21/11

180-Day

Mynx Vascular Closure Device Family Access Closure, Inc. Mountain View, CA 94043 Approval for a contract sterilization site, BeamOne, LLC located in Mountain View, California
P050017/S006

7/5/11

180-Day

6Fr Zilver Flex™ Vascular Stent Cook Incorporated Bloomington, IN 47404 Approval for a product line extension that represents modifications to the 6Fr version of the Zilver Vascular Stent. In addition, approval of minor changes to the stent and delivery system and the addition of a 100 mm length stent. The device, as modified, will be marketed under the trade name Zilver Flex™ 35 Vascular Stent and is

indicated for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic vascular disease of the iliac arteries up to 100 mm in length, with a reference vessel diameter of 5 to 9 mm. Patients must be suitable for PTA and stent treatment.

P050023/S014

7/1/11

135-Day

Corox OTW UP Steroid-Eluting Lead Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P050028/S017

7/7/11

135-Day

COBAS AmpliPrep/COBAS TaqMan HBV Test, v.2.0

 

Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for changes to in-process testing procedures for the Elution Buffer and Manganese Reagent to be implemented at the manufacturing site in Somerville, New Jersey.
P050040/S001

7/12/11

180-Day

SPOT-Light® HER2 CISH™ Kit Life Technologies Corporation

Frederick, MD

21704

Approval for a manufacturing site located in Frederick, Maryland.
P050042/S007

7/20/11

180-Day

ARCHITECT Anti-HCV Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P050043/S005

7/11/11

Real-Time

FISH-SP™ Advanced Compression Device Morris Innovative Research, Inc.

Bloomington, IN

47403

Approval for: adding a cuff stabilizer sheath, modifying the suture indicator knots and updating labeling. The device, as modified, will be marketed under the trade name FISH- SP™ Advanced Compression Device and is indicated for "...for hemostatic

closure of femoral artery access sites. The system is indicated for use in reducing time to

hemostasis and time to ambulation in patients who have undergone diagnostic procedures using

5, 6, 7 or 8 French procedural sheaths."

P050051/S006

7/20/11

180-Day

ARCHITECT AUSAB Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P060007/S005

7/20/11

180-Day

ARCHITECT HBsAg and ARCHITECT HBsAg Confirmatory Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P060010/S010

7/28/11

Real-time

The Spanner™ Temporary Prostatic Stent AbbeyMoor Medical, Inc.

Parkers Prairie, MN

56361

Approval for a design change to add an access tether, called the Shore Line to the device.
P060035/S003

7/20/11

180-Day

ARCHITECT CORE-M Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P070008/S004

7/1/11

135-Day

Corox OTW (-S) BP Steroid-Eluting Lead Biotronik, Inc.

Lake Oswego, OR

97035

Approval for a second manufacturer of the steroid collar, and second source of dexamethasone acetate (DXA) used for production of the steroid collar.
P070009/S011

7/15/11

180-Day

REALIZE® Pressure Recording System Ethicon Endo-Surgery, Inc. Cincinnati, OH 45242 Approval for the REALIZE® Pressure Recording System, indicated to record and display fluid pressure variations within a closed system by converting mechanical inputs to analog/digital electrical signals.
P070022/S013

7/5/11

135-Day

 

Adiana Permanent Contraception System Hologic, Inc.

Marlborough, MA

01752

Approval for minor changes to a damper test fixture and revision of the damper assembly process.
P080023/S003

7/20/11

180-Day

ARCHITECT CORE Abbott Laboratories Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte. Ltd. in Singapore.
P080027/S005

7/27/11

135-Day

OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.

Bethlehem, PA

18015

Approval for the option to automate the manufacturing process for assembly of the OraQuick® HCV Rapid Antibody Test.
P090018/S009

7/7/11

Real-Time

 

Esteem® Envoy Medical Corporation

St. Paul, MN

55110

Approval for the user interface software change to the Esteem Commander Programmer.
P100010/S008

7/15/11

Real-Time

Arctic Front® Cardiac Cryoablation Catheter Medtronic CryoCath LP

Quebec, Canada

Approval for sterilization and packaging changes.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810031/S039

7/21/11

Healon 10mg/ml, Healon GV 14mg/ml, Healon 5 23mg/ml Abbott Medical Optics, Incorporated

Santa Ana, CA

92705

Change the test method for bioburden testing of finished product prior to moist heat sterilization.

 

P810032/S060

7/21/11

PMMA Multi-Piece Posterior Chamber Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change from a manual proof-reading process to an automated proof-reading system.
P820003/S107

7/7/11

EPG Safety Cable and Disposable Cover Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P820003/S108

7/21/11

Plastic Cover for 5388 EPG, EPG Safety Cable and Safety ECG Electrode used with 6074 and 6074L Patient Cables Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P830061/S067

7/7/11

CapSure, Vitatron Crystaline, Vitatron Excellence+ and Vitatron Excellence PS+ Leads Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P830061/S068

7/27/11

CapSure, Vitatron Crystaline, Vitatron Excellence PS+ Leads Medtronic, Inc.

Mounds View, MN

55112

Addition of second supplier of silicone tubing.
P830061/S069

7/21/11

CapSure, Vitatron Crystalline, Vitatron Excellence + and Vitatron Excellence PS+ Families of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P840001/S189

7/6/11

Restore Family of Implantable Neurostimulators Medtronic Neuromodulation Minneapolis, MN

55432

Updating the welding equipment software at a vendor.
P840001/S190

7/7/11

Restore Family of Implantable Neurostimulators/ Itrel/Synergy Family of INS/SymMix Surgical Lead Medtronic Neuromodulation Minneapolis, MN 55432 Update statistical process control software.
P840001/S191

7/29/11

Intrel 3, Restore, SymMix, Pisces, Synergy Family Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P840060/S037

7/21/11

PMMA Single-Piece Posterior Chamber Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change from a manual proof-reading process to an automated proof-reading system.
P850051/S075

7/7/11

Vitatron Legacy IPG Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P850051/S076

7/21/11

Vitatron Legacy Family of IPGs Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P850089/S079

7/7/11

CapSure, CapSure SP, CapSure Z Novus, Vitatron Excellence S+,

Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse

II Leads

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P850089/S080

7/27/11

CapSure, CapSure Z Novus, Vitatron Excellence SS+, Vitatron Impulse II Leads Medtronic, Inc.

Mounds View, MN

55112

Addition of second supplier of silicone tubing.
P850089/S081

7/21/11

CapSure, CapSure Z Novus, CapSure SP Z, Vitatron Excellence S+, Vitatron Excellence SS+, Vitatron Impulse and Vitatron Impulse II Families of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P860004/S153

7/7/11

SynchroMed II Implantable Infusion Pump/InDura 1P Intrathecal Catheters/Intrathecal Catheter Medtronic Neuromodulation Minneapolis, MN 55432 Update statistical process control software.
P860004/S154

7/29/11

Synchromed Pumps, Indura Family Catheters, Intraspinal Trial Kits Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P880087/S019

7/21/11

PMMA Single- Piece Anterior Chamber Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change from a manual proof-reading process to an automated proof-reading system.
P890003/S230

7/7/11

CapSure Leads and Prodigy IPG w/Associated Kits, Cables and Port Pin Plugs Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P890003/S231

7/21/11

Capsure, CapSure Lead, and CapSure Model Families of Leads, Thera-1 DR and Prodigy Families of IPGs and Service Kit-Pacemaker Repair, Connector Port Pin Plug and ECG Cable Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P900060/S045

7/13/11

Carbomedics Prosthetic Heart Valve (CPHV) Sorin Group USA, Inc.

Arvada, CO

80004

Addition of a new molding supplier for the manufacturing of components used to package the finished device.
P900061/S104

7/7/11

Defibrillation Support Device and Associate Leads, Caps, Accessories and Sleeves Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P900061/S105

7/21/11

Accessory (upsizing sleeve), Accessory (upsizing sleeve) for unipolar, ACE Header, ACE, Lead End Pin Cap, Oval Patch Lead, Undefined and Defibrillation Support Device Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P920015/S079

7/7/11

Sprint, Sprint Quattro, Subcutaneous, Sub-Q Defibrillation,

Transvene SVC Leads and Accessories

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P920015/S080

7/21/11

“Y” Adaptor/ Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, DF-1 Connector Port Pin Plug, Tunneling Tool and Sprint Quattro, Subcutaneous, Transvene CS/SVC, Transvene DF1 and Transvene SVC Families of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P930014/S049

7/8/11

AcrySof and AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Optimized initiation processes and casting filtration for the device.
P930014/S050

7/21/11

AcrySof Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change from a manual proof-reading process to an automated proof-reading system.
P930014/S051

7/28/11

AcrySof Posterior Chamber Intraocular Lens Alcon Research Ltd. Fort Worth, TX

76134

Additional Laminar Air Flow hoods in the Alcon Ireland facility.
P930014/S052

7/21/11

ACRYSOF and ACRYSOF ReSTOR Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Fill/ Flush Extraction System for the ACRYSOF and ACRYSOF ReSTOR Intraocular lenses.
P930014/S053

7/26/11

AcrySof Posterior Chamber Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Removal of detergent from the cleaning process.
P930029/S031

7/7/11

RF Conductr MC, RF Contactr, RF Enhancr II, RF Marinr MC 7F,

RF Marinr SC 5F, RF Marinr Unipolar, RF Conductr MC

Ablation Catheters

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P930039/S057

7/7/11

CapSure, SureFix, Vitatron Crystalline ActFix, Vitatron and Pirouet S+ Leads Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P930039/S058

7/27/11

CapSure, Vitatron Crystalline ActFix Leads Medtronic, Inc.

Mounds View, MN

55112

Addition of second supplier of silicone tubing.
P930039/S059

7/21/11

CapSure, SureFix, Vitatron Crystalline ActFix and Vitatron Pirouet S+ Families of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P940015/S021

7/7/11

SynVisc® and Synvisc-One® Genzyme Corporation

Cambridge, MA

02142

Replacement of a polyethylene cylindrical tank with a stainless steel rotating blender system.
P950020/S045

7/20/11

Coronary Flextome Cutting Balloon Boston Scientific Corporation

Maple Grove, MN

55311

Use of an alternate mixer.
P950024/S032

7/7/11

CapSure Epicardial Pacing Lead Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P950024/S033

7/21/11

CapSure Epicardial Pacing Lead Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P960009/S119

7/6/11

Activa Family of Neurostimulators Medtronic Neuromodulation Minneapolis, MN

55432

Updating the welding equipment software at a vendor.
P960009/S120

7/7/11

Activa Family of INS/Soletra INS/ Kinetra INS Medtronic Neuromodulation

Minneapolis, MN

55432

Update statistical process control software.
P960009/S121

7/29/11

Activa Family, Soletra, Kinetra Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P970003/S128

7/11/11

VNS Therapy® System Pulse Generators Cyberonics, Inc.

Houston, TX

77058

Use of a new laser marker in the manufacturing process of the pulse generators.
P970003/S129

7/20/11

VNS Therapy® Pulse Generators Cyberonics, Inc.

Houston, TX

77058

Upgrade of the automated functional test system.
D970003/S130

7/1/11

Insigna, Nexus, and Altrua Family of Pacemakers Boston Scientific Corporation

St. Paul, MN

55112

Change to eliminate a shear strength test and a reduction in an ionic contamination monitor test frequency.
D970003/S131

7/7/11

Pulsar/Pulsar Max, Insigna, Altrua Brady Pulse Generators Boston Scientific Corporation

St. Paul, MN

55112

Update the document containing the temperature exposure process instruction.
P970004/S117

7/6/11

InterStim II Neurostimulator Medtronic Neuromodulation Minneapolis, MN

55432

Updating the welding equipment software at a vendor.
P970004/S118

7/7/11

InterStim Family of INS Medtronic Neuromodulation Minneapolis, MN 55432 Update statistical process control software.
P970004/S119

7/29/11

InterStim Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P970012/S086

7/7/11

Kappa 400 IPG Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P970012/S087

7/21/11

Kappa 400 Family of IPGs Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P970051/S078

7/21/11

Nucleus 24 Cochlear Implant System Cochlear Americas Centennial, CO

80111

Changes to: 1) the test systems (acoustic and wireless) to update test equipment and firmware;

2) additional tests for the digital sound processing memory; 3) modification to test

Limits; and 4) minor changes to the system user interface and test report format.

P970051/S080

7/22/11

Nucleus Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Modification to Clean Room 2.
P980006/S020

7/8/11

Bausch & Lomb PureVision (balafilcon A) Soft Contact Lenses Bausch & Lomb, Incorporated

Rochester, NY 14609

Add an additional raw material supplier.
P980016/S303

7/7/11

EnTrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso, Virtuoso II, Protecta DR, Protecta VR, Protecta XT DR, and Protecta XT VR Product Families Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P980016/S304

7/7/11

CapSure Lead and EnTrust, Intrinsic, Marquis, Maximo, Maximo

II, Protecta, Protecta XT, Secura, Virtuoso, and Virtuoso II ICDs

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980016/S306

7/15/11

Maximo II, Secura and Virtuoso II ICD Product Families Medtronic, Inc.

Mounds View, MN

55112

Six changes to Gen2 Hybrid Tester:

1) a change to the test decibel limit of the EGM CMR;

2) a change to the Telemetry B VizSense;

3) a change to the R034 Stress;

4) a change to the JTAG Full Energy delivery pulse width; 5) a change to LV1 Continuity; and 6) a change to the Current Drain AVVD RF Idd.

P980016/S307

7/13/11

Maximo II, Protecta, Protecta XT, Secura, Virtuoso II ICDs Medtronic, Inc.

Mounds View, MN 55112

Manufacturing process and location change for the diode used in the high voltage charging transformer.
P980016/S308

7/21/11

CapSure Family of Leads and Entrust, Intrinsic, Marquis, Maximo, Protecta DR/VR, Protecta XT DR/VR, Maximo II, Secura, Virtuoso and Virtuoso II Families of ICDs Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P980016/S309

7/29/11

Marquis VR ICD Medtronic, Inc.

Mounds View, MN

55112

Additional device models to be included in the update to sterile packaging sealing parameters.
P980035/S230

7/7/11

350 Series, EnRhythm, Sigma, and Advisa Product Families Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P980035/S231

7/7/11

Medtronic 350 Series, Adapta, Advisa, AT500, EnPulse,

EnRhythm, Relia, Sensia, Sigma and Versa IPGs

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980035/S232

7/21/11

350 Series, Adapta, EnRhythm, Relia, Sensia, Sigma, Advisa, AT500, EnPulse and Versa Families of IPGs Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P980035/S233

7/28/11

Adapta, Relia, Sensia, Versa Families of IPGs Medtronic, Inc.

Mounds View, MN

55112

Five Changes to Gen2 Hybrid Tester final test solution: 1) update to the Force Measure_ngt2 Module; 2) update the Pulse Amplitude and Pulse Width Test, Pulse Amplitude 7500 mV and Amplitude 7500 mV Test Sequences; 3) widen the tolerance of the stability check criteria for the Pulse Amplitude and Pulse Width Test ;

4) update the configuration settings for the Pulse Amplitude 7500 mV and Unipolar Bipolar Switch Test and the Inter-Chamber Crosstalk Test; and 5) update the Electrically Erasable Programmable Read Only Memory (EEPROM) Cyclic Redundancy Check (CRC).

P980035/S234

7/29/11

Medtronic 350 Series IPG Medtronic, Inc.

Mounds View, MN

55112

Additional device models to be included in the update to sterile packaging sealing parameters.
P980049/S064

7/1/11

Paradym VR and DR ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Alternate oven used for reflow soldering.
P980050/S063

7/7/11

Transvene CS/SVC Lead Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P980050/S064

7/21/11

Transvene CS/SVC (w/polyurethane sheath) Family of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P990001/S089

7/7/11

Vitatron DA+ C-Series and Vitatron DA+ T Series Family of Products Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P990001/S090

7/7/11

Vitatron DA+ C- Series and Vitatron DA+ T-Series IPGs Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P990001/S091

7/21/11

Vita, Vitatron DA+ C-Series and Vitatron DA+

T-Series Families of IPGs

Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P990020/S046

7/13/11

AneuRx AAAdvantage Stent Graft Medtronic Vascular Santa Rosa, CA

95403

Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P990034/S023

7/29/11

Side Catheter Accessory Port Kits, Including Bulk Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P000029/S069

7/28/11

Deflux Injectable Gel Schiff & Company

West Caldwell, NJ

07006

Relocation of the Quality Control Laboratory to a new location within

Q-Med AB ’s existing facility.

P000037/S023

7/20/11

On-X Prosthetic Heart Valve On-X Technologies, Inc.

Austin, TX

78752

Validations for a mass finishing process.
P010012/S269

7/28/11

Easytrak 2 Lead Boston Scientific Corporation

St. Paul, MN

55112

Change to the laser weld equipment used to manufacture pacing leads.
P010014/S032

7/28/11

Oxford® Partial Knee System Biomet, Inc.

Warsaw, IN

46581

Introduction of new equipment for cleaning and passivation of the metallic components of the Oxford® Partial Knee System.
P010015/S128

7/7/11

Syncra and Consulta CRT-P Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P010015/S130

7/7/11

Attain Leads, Consulta, InSync III and Syncra CRT-Ps Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P010015/S131

7/21/11

Attain Family of Leads and Syncra, Consulta, and InSync III Families of CRT-Ps Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P010015/S133

7/29/11

Syncra CRT-P, Consulta CRT-P, InSync CRT-P, InSync III CRT-P Medtronic, Inc.

Mounds View, MN

55112

Update to Process Operation Descriptions and the implementation of new test monitoring for packaging.
P010031/S257

7/7/11

Concerto, Concerto II Consulta, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II Product Families; Protecta and Protecta XT CRT-D Families Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P010031/S258

7/7/11

Concerto, Concerto II, Consulta, InSync Marquis, InSync II

Marquis, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II, Protecta, Protecta XT ICDs and

CRT-Ds

Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P010031/S260

7/15/11

Concerto II, Consulta and Maximo II CRT-D Product Families Medtronic, Inc.

Mounds View, MN

55112

Six changes to Gen2 Hybrid Tester: 1) a change to the test decibel limit of the EGM CMR; 2) a change to the Telemetry B VizSense; 3) a change to the R034 Stress; 4) a change to the JTAG Full Energy delivery pulse width; 5) a change to LV1 Continuity; and 6) a change to the Current Drain AVVD RF Idd.
P010031/S261

7/13/11

Concerto II, Consulta, Maximo II, Protecta, Protecta XT CRT-Ds Medtronic, Inc.

Mounds View, MN 55112

Manufacturing process and location change for the diode used in the high voltage charging transformer.
P010031/S262

7/21/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Marquis, InSync Maximo, Protecta, Protecta XT, InSync Sentry and Maximo II Families of

CRT-Ds

Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P010031/S263

7/29/11

Protecta CRT-D and XT CRT-D Medtronic, Inc.

Mounds View, MN

55112

Additional device models to be included in the update to sterile packaging sealing parameters.
P020009/S076

7/25/11

Express and Express 2 Coronary Stent Systems Boston Scientific Corporation

Maple Grove, MN

55311

Removal of an IPA wash step.
P030005/S078

7/1/11

Contak Renewal TR CRT-P Boston Scientific Corporation

St. Paul, MN

55112

Change to eliminate a shear strength test and a reduction in an ionic contamination monitor test frequency.
P030009/S056

7/27/11

Integrity Coronary Stent System Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Semi-Automation of one of the Integrity stent manufacturing work steps.
P030009/S057

7/27/11

Endeavor Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular, Inc.

Santa Rosa, CA

95403

Change in receiving inspection location for a component.
P030017/S121

7/27/11

Precision® Spinal Cord Stimulator System Boston Scientific Neuromodulation

Valencia, CA

91355

Add in-house equipment for the cable ablation process.
P030036/S033

7/7/11

SelectSecure Lead and Sleeve Kit Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P030036/S034

7/21/11

Anchoring Sleeve Kit and SelectSure Family of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P030052/S008

7/20/11

UroVysion Bladder Cancer Kit Assay Abbott Molecular, Inc.

Des Plaines, IL

60018

Implementation of an in-process validated test method for restriction Enzyme Digest Gel Electrophoresis (DNA Restriction Analysis), change in digest restriction enzymes used in the in-process test, implementation of an in-process validated test method for DNA Concentration Determination by UV/Vis Absorbance Spectrophotometry, and addition of an incoming screening test for Dextran Sulfate.
P040012/S040

7/7/11

Acculink Carotid Stent System Abbott Vascular, Inc.

Santa Clara, CA

05054

Use of an alternate Radial Force Tester.
P040016/S074

7/25/11

VeriFLEX (Liberté) Coronary Stent Systems Boston Scientific Corporation

Maple Grove, MN

55311

Removal of an IPA wash step.
P040020/S031

7/8/11

AcrySof and AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd. Fort Worth, TX 76134 Optimized initiation processes and casting filtration for the device.
P040020/S032

7/21/11

AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change from a manual proof-reading process to an automated proof-reading system.
P040020/S033

7/21/11

ACRYSOF and ACRYSOF ReSTOR Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Change in the Fill/ Flush Extraction System for the ACRYSOF and ACRYSOF ReSTOR Intraocular lenses.
P040020/S034

7/26/11

AcrySof ReSTOR Intraocular Lenses Alcon Research, Ltd.

Fort Worth, TX

76134

Removal of detergent from the cleaning process.
P040033/S021

7/27/11

Birmingham Hip Resurfacing (BHR) System Smith & Nephew

Memphis, TN

38116

Use of a new degreasing system at a contract manufacturer.
P040045/S024

7/1/11

VISTAKON (senofilcon A) Contact Lenses, Clear and Visibly Tinted with UV Blocker Johnson & Johnson Vision Care, Inc. Jacksonville, FL 32256 Implementation of an alternative test method for the raw material for VISTAKON.
P040047/S020

7/8/11

Coaptite Injectable Implant Merz Aesthetics, Inc. Franksville, WI

53126

Addition of an inspection test and associated equipment, for the Coaptite Injectable Implant syringe component.
P050020/S036

7/6/11

FreeStyle Navigator Continuous Glucose Monitoring System Abbott Laboratories Alameda, CA

94502

Update to their First Article Inspection (FAI) procedure.
P050037/S030

7/8/11

Radiesse Injectable Implant Merz Aesthetics, Inc. Franksville, WI

53126

Inclusion of bore gauge testing to incoming inspection of syringe barrels for the device.
P050044/S018

7/26/11

Vital Surgical Hemostat Orthovita, Inc.

Malvern, PA

19355

Use of an automated washer as an alternative to manual cleaning of equipment and components used in the production of Vitagel Surgical Hemostat.
P050047/S017

7/21/11

Juvéderm Hyaluronate Gel Implants Allergan

Goleta, CA

93117

Change in the sterilization validation method for the Juvéderm Hyaluronate Gel Implants.
P050049/S007

7/1/11

Abbott AxSYM HBsAg and HBsAg Confirmatory Abbott Laboratories Abbott Park, IL

60064

Addition of an HBsAg positive plasma supplier and a change to quality control testing.
P050052/S033

7/8/11

Radiesse Injectable Implant Merz Aesthetics, Inc. Franksville, WI

53126

Inclusion of bore gauge testing to incoming inspection of syringe barrels for the device.
P060008/S073

7/25/11

Taxus Liberté Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation

Maple Grove, MN

55311

Removal of an IPA wash step.
P060027/S031

7/1/11

Paradym CRT-D 8750 ELA Medical, Inc./ Sorin Group

Plymouth, MN

55441

Alternate oven used for reflow soldering.
P060039/S027

7/7/11

Attain Starfix Lead Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P060039/S028

7/21/11

Attain StarFix Family of leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P070007/S031

7/13/11

Talent Thoracic Stent Graft Medtronic Vascular Santa Rosa, CA

95403

Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P070008/S025

7/22/11

Corox OTW-L BP Leads Biotronik, Inc.

Lake Oswego, OR

97035

Approval for an alternate sterilizer.
P070015/S074

7/1/11

XIENCE V Everolimus Eluting Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change to a manufacturing process of supplied acetone.
P070022/S021

7/26/11

Adiana Permanent Contraception System Hologic, Inc.

Marlborough, MA

01725

Changes to the manufacturing and soldering process of a component of the device.
P070027/S030

7/13/11

Talent Abdominal Stent Graft Medtronic Vascular Santa Rosa, CA

95403

Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.
P080006/S030

7/7/11

Attain Ability, Attain Ability Plus and Attain Ability Straight Leads Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P080006/S031

7/13/11

Attain Ability Plus LV Leads Medtronic, Inc.

Mounds View, MN

55112

Transfer of incoming inspection activities for specific components to a different facility.
P080006/S032

7/21/11

Attain Ability, Attain Ability Plus and Attain Ability Straight Families of Leads Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P080025/S009

7/6/11

InterStim II Neurostimulator Medtronic Neuromodulation Minneapolis, MN

55432

Updating the welding equipment software at a vendor.
P080025/S010

7/7/11

InterStim Family of INS Medtronic Neuromodulation Minneapolis, MN 55432 Update statistical process control software.
P080025/S011

7/29/11

InterStim Family of Implantable Neurostimulators, Leads, Extensions and Accessory Kits Medtronic Neuromodulation

Minneapolis, MN

55432

Procedure modification to meet the requirements of updated industry standards.
P090013/S027

7/7/11

Revo MRI Product Family Medtronic, Inc.

Mounds View, MN

55112

Upgrade to the auto- welder equipment software.
P090013/S029

7/7/11

CapSure Fix Lead and Revo MRI IPG Medtronic, Inc.

Mounds View, MN

55112

Upgrade to statistical process control off-the-shelf software that will be used by Medtronic Energy and Component Center (MECC).
P090013/S030

7/21/11

CapSure Fix Family of Leads and Revo MRI Family of IPGs Medtronic, Inc.

Mounds View, MN

55112

Updating the EO Residual Test procedure in response to a new standard.
P100023/S006

7/13/11

ION Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN 55311

Elimination of two redundant inspection steps.
P100023/S007

7/25/11

ION (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Removal of an IPA wash step.
P100023/S008

7/27/11

ION™ (TAXUS Element) Paclitaxel- Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Alternate inherent viscosity test method for testing of Aeson-blended resin and annealed gradient outer tubing component, and an up of associated specifications.
P100023/S010

7/27/11

ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Software upgrades to the stent inspection system.
P100029/S005

7/1/11

Trifecta Valve St. Jude Medical, Inc.

St. Paul, MN

55117

Automated method for stent dimensional inspection.
P100029/S006

7/7/11

Trifecta Valve St. Jude Medical, Inc.

St. Paul, MN

55117

Addition of an alternate vendor for stent tubing material.
P100031/S001

7/22/11

Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti- HBc on the MODULAR ANALYTICS E170 Immunoassay Analyzer Roche Diagnostics

Indianapolis, IN

46250

 

Change within the manufacturing site to increase production capacity for a component of the streptavidin- coated microparticles used in both of these assays.
P100032/S001

7/22/11

Elecsys Anti-HBc Immunoassay and Elecsys PreciControl Anti- HBc on the Elecsys 2010 Immunoassay Analyzer Roche Diagnostics

Indianapolis, IN

46250

 

Change within the manufacturing site to increase production capacity for a component of the streptavidin- coated microparticles used in both of these assays.
P100040/S006

7/13/11

Valiant Thoracic Stent Graft Medtronic Vascular Santa Rosa, CA

95403

Reduction in the number of in-process inspection steps in two manufacturing processes of the delivery systems.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 76

Summary of PMA Originals Under Review

Total Under Review: 96

Total Active: 42

Total On Hold: 54

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 682

Total Active: 471

Total On Hold: 211

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 6

Supplements: 60

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 76

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 219.8

FDA Time: 114.1 Days MFR Time: 105.7 Days

SOURCE

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