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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
P050027

5/28/10

Karl Storz Photodynamic Diagnostic D-Light C (PDD) System Karl Storz Endoscopy-America, Inc.

El Segundo, CA

90245

Approval for the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System. The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810031/S037

5/20/10

Real-Time

Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon®, Healon GV® and Healon5® Abbott Medical Optics, Inc.

Santa Ana, CA

92705

Approval for a change in packaging for two individual blister tray packs (Healon® & Healon5®) to be packed in a single carton box.
P820003/S093

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850051/S072

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P850079/S047

5/3/10

180-Day

CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear CooperVision

Norfolk, VA

23507

Approval for the trade name CLEAR SOFT. The device, as modified, will be

marketed under the trade name CLEAR SOFT and is indicated for:

CLEAR SOFT Sphere (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by

persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.

CLEAR SOFT Toric (methafilcon A) Soft Contact lenses are indicated for the correction

of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons

with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic

corrections from

-0.25 to -5.00 diopters.

The CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights/7 days of continuous wear. It is

recommended that the contact lens wearer first be evaluated on a daily wear schedule. If

successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner.

Eye care practitioners may prescribe the lens for frequent replacement wear with cleaning, disinfecting and scheduled replacements.

P860019/S252

5/11/10

Real-Time

Quantum Maverick OTW, Apex OTW, Maverick OTW, and Maverick XL Monorail PTCA Dilatation Catheters Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P890003/S186

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P890003/S188

5/11/10

Real-Time

Medtronic® CareLink Device Data Management Application (DDMA) Model 2491 Medtronic, Inc.

Mounds View, MN

55112

Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P900061/S087

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P910023/S226

5/7/10

180-Day

Fortify VR/DR St. Jude Medical Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for the Fortify VR/DR pulse generators.
P910077/S104

5/19/10

Real-Time

Zoom Latitude Programmer Boston Scientific CRM

St. Paul, MN

55112

Approval for a minor design change to the Model 3120 Zoom Latitude programmer and an alternate supplier for the hard drive component in the programmer.
P930022/S011

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P950037/S072

5/7/10

180-Day

Evia/Entovis Pulse Generators Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Evia/Entovis Pulse Generators.
P960013/S058

5/19/10

Real-Time

OptiSense St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for new stylets to be included in the OptiSense Model 1999 lead package.
P970003/S109

5/18/10

Special

VNS Therapy System Cyberonics, Inc.

Houston, TX

77058

Approval for a labeling modification regarding the internal clock reset in the Model 100, 101, 102 and 102R Implanted pulse Generators (IPGs).
P970008/S049

5/13/10

Real-Time

Urologix Targis® System Urologix, Inc.

Minneapolis, MN

55447

Approval to replace an obsolete touchscreen and modify the microwave generator to improve design margins.
P970012/S065

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P970021/S028

5/13/10

180-Day

Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc.

Somerville, NJ

08876

Approval for updated professional labeling to reflect the results of the Post-Approval Study required as a condition of approval to Supplement 14.
P970051/S057

5/14/10

135-Day

Nucleus 24 Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Approval for a change to the material used in the manufacturing of the microphone protector cover for the CP810 Sound Processor.
P980016/S232

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980016/S234

5/11/10

Real-Time

Medtronic® Secura® DR/VR D224DRG/ D224VRC, Maximo® DR/VR D284DRG/ D284VRC, Virtuoso II DR/VR D274DRG/ D274VRC Implantable Cardioverter Defibrillators Medtronic, Inc.

Mounds View, MN

55112

Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P980035/S161

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P980050/S047

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990001/S064

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P990020/S039

5/21/10

180-Day

ANEURx AAAdvantage Stent Graft Delivery System Medtronic Vascular

Santa Rosa, CA

95403

Approval for a sterilization site located at Isotron Ireland, LTD., in Offaly, Ireland.
P990027/S010

5/18/10

180-Day

Bausch & Lomb Technolas T217z Zyoptix Laser System Biomed Research, Inc.

Lutz, FL

33558

Approval for the following changes: 1) Removal of a redundant fluence test;

2) Introduction of a new scanner system from GSI to the laser System:

3) Extrapolation of the Wavefront data in the Diagnostic Zywave Software;

4) New ZRS (Zyoptix Remote Support) Software to monitor the performance of the

laser and diagnostic devices remotely via the internet;

5) Modification of the ZRS to include TruLink, an enhancement to the ZRS system;

6) Introduction of a new OP field illumination in the laser system;

7) Change of the video chip in the CCD Lenslet Camera DMK4002-IR; and

8) Change in the supplier of the temperature control unit in the laser system.

P990038/S013

5/21/10

135-Day

ETI-MAK-2 PLUS & ETI-MAK-2 PLUS HBsAg Confirmatory Test DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990041/S012

5/21/10

135-Day

ETI-AB-EBK PLUS DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990042/S009

5/21/10

135-Day

ETI-AB-AUK PLUS DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990043/S013

5/21/10

135-Day

ETI-EBK PLUS DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990044/S010

5/21/10

135-Day

ETI-CORE-IGMK PLUS DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990045/S010

5/21/10

135-Day

ETI-AB-COREK PLUS DiaSorin, Inc.

Stillwater, MN

55082

Approval for changing BSA raw material.
P990066/S035

5/20/10

180-Day

GE-Healthcare Senographe Essential Digital Mammography System GE Healthcare

Milwaukee, WI

53201

Approval for a modification to the amorphous silicon array design used in the detector of the Senographe Essential full field digital mammography system. The proposed modifications include the following:

1) Reducing the number of layers in the detector amorphous silicon array; 2) Change in the detector firmware to allow the detector configuration to be communicated to the system Image Detector Controller (IDC); 3) IDC software to automatically determine if a detector with the proposed modification is installed on the system and properly select the proper configuration table; and

4) Corresponding changes in the incoming acceptance criteria testing station for the modified detector.

P000009/S035

5/7/10

180-Day

Evia/Entovis Pulse Generators Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Evia/Entovis Pulse Generators.
P000021/S013

5/19/10

180-Day

Dimension Vista® TPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the following changes:

1) Detection technology from spectrophotometry to chemiluminesence;

2) Appropriate reagent process changes to accommodate chemiluminesence detection;

3) Usage on the Dimension Vista® 1500 System;

4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista®

1500 Systems connected by a sample track transport mechanism;

5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical

Workcell Laboratory Automation System; and

6) The new Dimension Vista® PSA Calibrator for use with the Dimension Vista® TPSA and FPSA methods.

The device, as modified, will be marketed under the trade name Dimension Vista® TPSA Flex

reagent cartridge and is indicated for the following uses:

The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate

specific antigen (PSA) in human serum and plasma on the Dimension Vista® System:

1) As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) As an aid in the

management (monitoring) of prostate cancer patients.

The Dimension Vista PSA calibrator will be marketed separately for use with the Dimension

Vista TPSA Flex reagent and is indicated for the calibration of Total (TPSA) and Free (FPSA) Prostate Specific Antigen methods on the Dimension Vista® Systems.

P000021/S015

5/27/10

180-Day

Dimension TPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the Dimension TPSA Flex reagent cartridge on the Dimension EXL with LM System.
P000054/S024

5/17/10

Special

INFUSE® Bone Graft Medtronic Sofamor Danek

Memphis, TN

38132

Approval for changes to the patient information brochure.
P000058/S036

5/17/10

Special

INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device Medtronic Sofamor Danek

Memphis, TN

38132

Approval for changes to the patient information brochure.
P010003/S015

5/12/10

Special

BioBlue® Surgical Adhesive CryoLife, Inc.

Kennesaw, GA

30144

Approval for clarification regarding one of the warnings in the Instructions for Use (IFU).
P010015/S082

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010030/S019

5/21/10

Real-Time

LifeVest Wearable Defibrillator WCD 4000 Zoll Lifecor Corporation

Pittsburgh, PA

15238

Approval for a component value change to the ECG electrode buffer boards to improve ECG amplifier common mode rejection.
P010031/S191

5/11/10

Real-Time

Various Device Families Medtronic, Inc.

Mounds View, MN

55112

Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer.
P010031/S193

5/11/10

Real-Time

Medtronic® Consulta CRT-D D224TRK, Maximo® II CRT-D D284TRK, Concerto� II D274TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization Medtronic, Inc.

Mounds View, MN

55112

Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events.
P020004/S049

5/5/10

135-Day

GORE EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates

Flagstaff, AZ

86001

Approval for an expansion of the manufacturing environment.
P020004/S050

5/12/10

Real-Time

GORE EXCLUDER® AAA Endoprosthesis W.L. Gore and Associates

Flagstaff, AZ

86001

Approval for the removal of the center knot sleeve attachment.
P020009/S061

5/11/10

Real-Time

Express OTW Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P020027/S009

5/17/10

180-Day

Dimension Vista® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the following changes:

1) Detection technology from spectrophotometry to chemiluminesence;

2) Appropriate reagent process changes to accommodate chemiluminesence detection;

3) Usage on the Dimension Vista® 1500 System;

4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista®

1500 Systems connected by a sample track transport mechanism; and

5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical

Workcell Laboratory Automation System.

The device, as modified, will be marketed under the trade name Dimension Vista® FPSA Flex

reagent cartridge and is indicated for:

The FPSA method for the Dimension Vista® System is an in vitro diagnostic test intended to quantitatively measure free prostate

specific antigen (FPSA) in human serum and plasma. Measurements of FPSA are used in conjunction with total PSA (TPSA) method on Dimension Vista® System to calculate FPSA to TPSA ratio expressed as a percent FPSA. The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 1.0 ng/mL and DRE findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer.

P020027/S010

5/27/10

180-Day

Dimension FPSA Flex Reagent Cartridge Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the Dimension FPSA Flex reagent cartridge on the Dimension EXL with LM System.
P030017/S098

5/6/10

Real-Time

Precision® Spinal Cord Stimulation (SCS) System Boston Scientific Neuromodulation Corp.

Valencia, CA

91355

Approval for a consolidation of three separate instruction manuals (i.e., Physician Implant, Physician Lead, and Physician Surgical Lead Manuals) into a single manual, the Physician System Clinical manual.
P030025/S085

5/11/10

Real-Time

Taxus Express2 Coronary Stent System, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P030054/S130

5/10/10

180-Day

QuickFlex µ Left Ventricular Lead St. Jude Medical Cardiac Rhythm Management Division

Sylmar, CA

91342

Approval for the QuickFlex µ Model 1258TLeft Ventricular Lead.
P030054/S141

5/7/10

180-Day

Unify CRT-D St. Jude Medical Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for the Unify CRT-D pulse generators.
P030054/S146

5/3/10

180-Day

Merlin Patient Care System Programmer Model 3650 St. Jude Medical Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for: 1) The addition of the pacing systems analyzer (PSA) model EX3100. The model EX3100 also includes accessories:

a) Merlin Antenna Adapter EX3190;

b) Merlin Cable Adapter EX3170; and c) Merlin â??Mâ? Adapter EX3180; and 2) The addition of the Model 3330 version 10.1.1 software.

P040002/S027

5/12/10

Real-Time

PowerLink System Endologix, Inc.

Irvine, CA

92618

Approval for new PowerLink system models, including bifurcated devices with new lengths and diameters, limb extensions with new lengths, and aortic extensions with new lengths.
P040016/S054

5/11/10

Real-Time

VeriFLEX OTW Bare-Metal Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P040034/S016

5/28/10

180-Day

DuraSeal® Dural Sealant System Confluent Surgical, Inc.

Bedford, MA

01730

Approval to update the contents of the DuraSeal Package Insert based on the results of the post-approval study.
P040043/S033

5/25/10

Real-Time

GORE TAG Thoracic Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Approval for a new 22 mm constraining sleeve size to be used in the 40 mm diameter TAG device.
P050023/S024

5/7/10

180-Day

Evia/Entovis Pulse Generators Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Evia/Entovis Pulse Generators.
P050033/S008

5/24/10

Special

Elevess Anika Therapeutics, Inc.

Bedford, MA

01730

Approval for revision of the physician and patient labels to include updates on the post market adverse event experience with the device.
P060002/S006

5/18/10

180-Day

Flair Endovascular Stent Graft C.R. Bard

Tempe, AZ

85281

Approval of the post-approval protocol.
P060006/S006

5/28/10

180-Day

Expressâ?¢ SD Renal Monorailâ?¢ Premounted Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for reinstatement of a secondary sterilization site formerly owned by Steris Isomedix Services, Inc. (Steris) located in Coventry, Rhode Island.
P060006/S010

5/11/10

Real-Time

Expressâ?¢ SD Renal Monorailâ?¢ Premounted Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P060008/S045

5/11/10

Real-Time

TAXUS® Liberté® OTW Paclitaxel-Eluting Coronary Stent System, Taxus Liberte Atom OTW Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for material and specification changes to the strain relief.
P060008/S047

5/17/10

Real-Time

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for MR compatibility labeling changes to the Directions for Use (DFU) and Patient Information Guide (PG) for the TAXUS Liberté Monorail (MR) and Over-the-Wire (OTW) Stent Delivery Systems.
P060040/S010

5/7/10

180-Day

Heartmate II Left Ventricular Assist System Thoratec Corporation

Pleasanton, CA

94588

Approval of the post-approval study protocol.
P070008/S011

5/7/10

180-Day

Evia/Entovis Pulse Generators Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the Evia/Entovis Pulse Generators.
APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790007/S025

5/28/10

Hancock® I Low Porosity and Modified Orifice Valved Conduit Medtronic, Inc.

Santa Ana, CA

92705

Addition of Gorditos Meats as an alternate supplier.
P810046/S238

5/13/10

Voyager® NC Coronary Dilatation Catheter Abbott Vascular, Inc.

Temecula, CA

92591

Change in the extrusion process for the tubing used to manufacture the Voyager® NC Coronary Dilatation Catheterâ??s 3.50 mm through 5.00 mm balloons.
P830061/S051

5/19/10

CapSure Sense, Vitatron Medtronic, Inc.

Mounds View, MN

55112

Addition of a second source supplier of electrode components.
P840001/S152

5/20/10

Restore Implantable Stimulators Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of the supplemental Automated Optical Inspection (AOI).
P840001/S153

5/27/10

RestoreULTRA Implantable Neurostimulator Medtronic Neuromodulation

Minneapolis, MN

55432

Change to qualify a connector rework process for the device manufacturing processes at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico.
P860004/S127

5/20/10

Personal Therapy Manager Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of the supplemental Automated Optical Inspection (AOI).
P860019/S255

5/2710

Apexâ?¢ Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter Boston Scientific

Maple Grove, MN

55311

Alternate sterilization cycle to be used at Isotron, Tullamore, Ireland.
P870078/S009

5/28/10

Hancock® Porcine Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of Gorditos Meats as an alternate supplier.
P890003/S190

5/14/10

Carelink Programmer Medtronic, Inc.

Mounds View, MN

55112

Change to the antenna support, manufacturing process changes related to the antenna support change, and changes to an antenna test.
P890064/S022

5/17/10

 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.

Gaithersburg, MD

20878

Change in supplier for the reagent in the device.
P890064/S023

5/17/10

 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.

Gaithersburg, MD

20878

Enabling the existing barcode reader configuration within the equipment software during the production of the device.
P890064/S024

5/17/10

 digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test Qiagen Gaithersburg, Inc.

Gaithersburg, MD

20878

Scale-up in the production of a component in the device.
P910073/S083

5/21/10

Reliance Family of Leads Boston Scientific Corporation

St. Paul, MN

55112

Replacement of existing automated measuring equipment.
P930039/S037

5/19/10

CapSureFix Novus, Vitatron Medtronic, Inc.

Mounds View, MN

55112

Addition of a second source supplier of electrode components.
P940031/S067

5/20/10

Discovery SR and DR Boston Scientific Corporation

St. Paul, MN

55112

Elimination of the outer sleeve wash step.
P950029/S052

5/26/10

Symphony, Rhapsody, Reply, Reply (V2), and Esprit Family of Pacemakers ELA Medical, Inc.

Plymouth, MN

55441

Change in location of the hybrid electronic module subcomponent manufacturing.
P950037/S080

5/13/10

Sterox S and Dextrus Family of Implantable Pacemaker Pulse Generators and Programmers Biotronik, Inc.

Lake Oswego, OR

97035

Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P960009/S082

5/20/10

Activa Family of Implantable Stimulators Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of the supplemental Automated Optical Inspection (AOI).
P960013/S059

5/13/10

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

Sylmar, CA

91342

Change in MCRD manufacturing process.
P960030/S030

5/13/10

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

Sylmar, CA

91342

Change in MCRD manufacturing process.
P960040/S221

5/19/10

Confient and Vitality HE Families of Pulse Generators Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Plating change to the reed switch component.
P960040/S222

5/19/10

Ventak Prizm, Ventak Prizm 2, Vitality,

Vitality HE,

Vitality 2,

Vitality AVT, and Confient Families of ICDs

Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Multiple cleaning and component testing changes for the crystal oscillator component.
P960040/S223

5/20/10

Confient and Vitality Families of ICDs Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Changes in the suppliers for thin-film resistors.
P960043/S071

5/5/10

Perclose® AT 6F and Perclose® ProGlide� Suture Medicated Closure Systems Abbott Vascular, Inc.

Redwood City, CA

94063

Addition of an alternate supplier for two overmolded components.
D970003/S118

5/19/10

Altrua Family of IPGs Boston Scientific Corporation

St. Paul, MN

55112

Changes for hybrid assembly transfer, a new laser marking tool, an automated solder ball shear inspection test, and the removal of a pre-screening inspection.
D970003/S119

5/20/10

Nexus I Entra SSIR, Nexus I Entra SSI, Nexus I Entra DDD, Nexus I Entra DDDR, Nexus I Plus DDDR, Discovery II SR, Insignia I Entra SSI, Insignia I Entra DDD, Insignia I Entra DDDR, Insignia I Entra SSIR, Insignia I Ultra DDDR, Insignia I Plus DDDR, Intelis II DR, and Intelis II SR Boston Scientific Corporation

St. Paul, MN

55112

Elimination of the outer sleeve wash step.
P970004/S085

5/20/10

Interstim iCOn Patient Programmer Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of the supplemental Automated Optical Inspection (AOI).
P970027/S008

5/13/10

AxSYM Anti-HCV Abbott Laboratories Diagnostic Division

Abbott Park North, IL

60064

Change to the efficacy testing performed on new incoming lots of conjugate concentrate for the device.
P970031/S029

5/28/10

Freestyle® Aortic Root Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of Gorditos Meats as an alternate supplier.
P980016/S236

5/12/10

EnTrust ICD, Virtuoso ICD, Intrinsic, Marquis, Maximo,

Maximo II DR/VR, Virtuoso II DR/VR, Secura DR ICD, Secura VR ICD

Medtronic, Inc.

Mounds View, MN

55112

Additional supplier for the plating process.
P980023/S040

5/13/10

Linox SD and Linox S Family of ICD Pacing Leads Biotronik, Inc.

Lake Oswego, OR

97035

Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P980035/S165

5/12/10

EnRhythm IPG Medtronic, Inc.

Mounds View, MN

55112

Additional supplier for the plating process.
P980040/S033

5/20/10

TECNIS® Multifocal One-Piece Intraocular Lens Advanced Medical Optics, Inc.

Santa Ana, CA

92705

Change in the sterilization cycle parameters for the device.
P980043/S025

5/13/10

Hancock® II Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Change to the valve holder assembly process and inspection documents.
P980043/S026

5/28/10

Hancock® II Porcine Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of Gorditos Meats as an alternate supplier.
P980049/S056

5/26/10

Paradym Family of ICDs ELA Medical, Inc.

Plymouth, MN

55441

Change in location of the hybrid electronic module subcomponent manufacturing.
P990001/S066

5/12/10

DA+ C-Series,

DA+ T-Series

Medtronic, Inc.

Mounds View, MN

55112

Additional supplier for the plating process.
P990037/S030

5/7/10

Vascular Solutions Duett Sealing Device Vascular Solutions

Minneapolis, MN

55369

Change in the quality control device used to monitor the sterilization process from an in-house manufactured sterilization process control device (SPCD) to a commercially purchased PCD.
P990064/S032

5/13/10

Mosaic® Porcine Bioprosthesis Medtronic, Inc.

Sana Ana, CA

92705

Change to the valve holder assembly process and inspection documents.
P990064/S033

5/28/10

Mosaic® Porcine Bioprosthesis Medtronic, Inc.

Santa Ana, CA

92705

Addition of Gorditos Meats as an alternate supplier.
P990066/S036

5/27/10

Senographe Digital Mammography System GE Healthcare

Waukesha, WI

53188

Change in supplier and replacement of obsolete computer systems.
P000006/S019

5/6/10

Titan Inflatable Penile Prosthesis Coloplast Corp.

Minneapolis, MN

55411

Use of an automated piece of equipment in dipping large size Titan cylinders.
P000039/S036

5/28/10

Amplatzer® Septal Occluder AGA Medical Corporation

Plymouth, MN

55442

Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P010012/S234

5/20/10

Cognis,

Contak Renewal, Contak Renewal 3 RF, Contak Renewal 3 HE,

Contak Renewal 3 RF HE, Contak Renewal 3, Contak Renewal 3 AVT

HE, Contak Renewal 4 AVT, Contak Renewal 4 AVT HE, Livian LV1

SE, and Livian LV1 HE

Boston Scientific Corporation

St. Paul, MN

55112

Elimination of the outer sleeve wash step.
P010012/S240

5/19/10

Livian, Renewal 3, Renewal 3RF, and Renewal 3 AVT Families of Pulse Generators Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Plating change to the reed switch component.
P010012/S241

5/19/10

Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Contak Renewal 3 RF, Contak Renewal 3 RF HE, Livian SE, and Livian HE Families of CRT-Ds Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Multiple cleaning and component testing changes for the crystal oscillator component.
P010012/S242

5/20/10

Contak Renewal 3 and Livian Families of CRT-Ds Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Changes in the suppliers for thin-film resistors.
P010021/S018

5/20/10

Vitros Immunodiagnostics Products Anti-HCV Reagent Pack and Calibrator Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Addition of a new supplier of a raw material used in the manufacture of the Vitro Anti-HCV Calibrator.
P010031/S195

5/12/10

Concerto CRT-D, InSync II Marquis, Consulta CRT-D, InSync II Protect, InSync III Marquis, InSync Marquis, InSync II Protect, Maximo II CRT-D Medtronic, Inc.

Mounds View, MN

55112

Additional supplier for the plating process.
P010047/S003

5/25/10

Neomend ProGelâ?¢ Pleural Air Leak Sealant NeoMend, Inc.

Irvine, CA

92618

Modification of a test procedure used to determine the percent protein of human serum albumin in the component manufacturing process and for final release.
P020009/S063

5/13/10

Express 2® Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.
P020024/S029

5/28/10

Amplatzer® Duct Occluder AGA Medical Corporation

Plymouth, MN

55442

Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P020047/S019

5/21/10

Multi-Link Vision® OTW Coronary Stent System and Multi-Link Mini Vision® OTW Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change to the extrusion manufacturing process.
P030005/S062

5/21/10

Contak Renewal TR Boston Scientific Corporation

St. Paul, MN

55112

Change in test limits.
P030005/S063

5/19/10

Contak Renewal TR Family of CRT-Ps Boston Scientific Corporation

Cardiac Rhythm Management

St. Paul, MN

55112

Multiple cleaning and component testing changes for the crystal oscillator component.
P030005/S064

5/20/10

Contak Renewal TR Boston Scientific Corporation

St. Paul, MN

55112

Elimination of the outer sleeve wash step.
P030009/S041

5/13/10

Driver & Microdriver Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Addition of process equipment.
P030025/S088

5/13/10

TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P030025/S089

5/13/10

TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Changes to process software.
P030025/S090

5/13/10

TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.
P030031/S029

5/27/10

Navistar RMT Thermocool Catheter Biosense Webster, Inc.

Diamond Bar, CA

91765

Addition of second source supplier of the Pebax 40D Tubing.
P040002/S028

5/13/10

Powerlink® Stent Graft with IntuiTrak Delivery System Endologix, Inc.

Irvine, CA

92618

Change to the hemostasis handle assembly of the device.
P040016/S056

5/13/10

VeriFLEX® Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.
P040016/S057

5/13/10

VeriFLEX (Liberté®) Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change from a manual in-process inspection to an automated in-process inspection.
P040036/S022

5/27/10

Celsius RMT Thermocool Catheter Biosense Webster, Inc.

Diamond Bar, CA

91765

Addition of second source supplier of the Pebax 40D Tubing.
P040040/S013

5/28/10

Amplatzer® Muscular VSD Occluder AGA Medical Corporation

Plymouth, MN

55442

Change in the supplier of the stitching yarn used in select Nitinol occlusion devices.
P040044/S031

5/4/10

Mynx Vascular Closure Device Access Closure, Inc.

Mountain View, CA

04043

Change to a component joining process.
P050007/S025

5/21/10

StarClose SE® Vascular Closure System Abbott Vascular, Inc

Redwood City, CA

94063

Addition of a post-cure process to the manufacturing of the Release Rod component.
P050010/S005

5/26/10

ProDisc-L Total Disc Replacement Synthes Spine

West Chester, PA

19380

New Mahr perthometer that uses a different software version than the existing Mahr perthometer used to measure surface toughness.
P050010/S006

5/26/10

ProDisc-L Total Disc Replacement Synthes Spine

West Chester, PA

19380

Upgrade of the Rofin Baasel Software, which controls the etching machine, from version 1.0.54 to 1.0.61.
P050023/S030

5/13/10

 

Lumax Family of ICDs and CRT-Ds Biotronik, Inc.

Lake Oswego, OR

97035

Change in packaging to the inner and outer bags of the sterilized stylet accessories.
P060006/S012

5/13/10

Express® SD Renal Monorail® Premounted Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.
P060008/S049

5/13/10

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station.
P060008/S050

5/13/10

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Changes to process software.
P060008/S051

5/13/10

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.
P060008/S052

5/13/10

TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change from a manual in-process inspection to an automated in-process inspection.
P060022/S007

5/19/10

Akreos® Posterior Chamber Intraocular Lens Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Elimination of the Ophthalmic Irrigation Solution Specification of the lens storage solution.
P060027/S023

5/26/10

Paradym Family of CRT-Ds ELA Medical, Inc.

Plymouth, MN

55441

Change in location of the hybrid electronic module subcomponent manufacturing.
P070015/S034

5/14/10

XIENCE V® and PROMUS� Everolimus Eluting Coronary Stent Systems Abbott Vascular

Temecula, CA

92591

Change to the balloon manufacturing process.
P070015/S035

5/21/10

Promus� OTW Everolimus-Eluting Coronary Stent System and Xience V® OTW Everolimus-Eluting Coronary Stent System Abbott Vascular

Temecula, CA

92591

Change to the extrusion manufacturing process.
P090003/S001

5/13/10

Express® LD Iliac Premounted Stent System Boston Scientific Corporation

Cardiovascular

Maple Grove, MN

55311

Change to the software used during a step in the stent manufacturing process.

Summary of PMA Originals & Supplements Approved

Originals: 1

Supplements: 65

Summary of PMA Originals Under Review

Total Under Review: 82

Total Active: 34

Total On Hold: 48

Number Greater Than 180 Days: 6

Summary of PMA Supplements Under Review

Total Under Review: 591

Total Active: 386

Total On Hold: 205

Number Greater Than 180 Days: 17

Summary of All PMA Submissions Received

Originals: 3

Supplements: 79

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 65

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 144.7

FDA Time: 91.4 Days MFR Time: 53.3 Days

    

SOURCE

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