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PMA Final Decisions for February 2011

Wed, 04/06/2011 - 8:38am
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
P080003

2/11/11

Selenia Dimensions 3D System Hologic, Inc.

Bedford, MA

01730

Approval for the Selenia Dimensions 3D System. This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as 2D mammography systems for screening mammograms. Specifically, the Selenia Dimensions system can be used to acquire 2D digital mammograms and 3D mammograms. The screening examination will consist of a 2D image set or a 2D and 3D image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
P090013

2/8/11

Revo MRI™ SureScan™ Pacing System Medtronic, Inc.

Mounds View, MN

55112

Approval for the Revo MRI

SureScan Pacing System, which consists of the Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG, the Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead, and the Revo MRI™ Software Application Model SW018. This system is indicated as follows:

The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for use as a system consisting of a Revo MRI SureScan IPG implanted with two CapSure Fix MRI™

SureScan™ 5086MRI leads. A complete system is required for use in the MRI environment.

The Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG is indicated for the

following:

1) Rate adaptive pacing in patients who may benefit from increased pacing rales

concurrent with increases in activity;

2) Accepted patient conditions warranting chronic cardiac pacing include:

a) symptomatic paroxysmal or permanent second-degree or third-degree AV block;

b) symptomatic bilateral bundle branch block;

c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders; and

d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some

forms of symptomatic tachyarrhythmias.

The device is also indicated for dual chamber and atrial tracking modes in patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically

indicated for treatment of conduction disorders that require restoration of both rate and AV

synchrony, which include:

1) Various degrees of AV block to maintain the atrial contribution to cardiac output; and

2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent

sinus rhythm.

Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrhythmia in

bradycardia patients with one or more of the above pacing indications.

Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmia in bradycardia patients with atrial septal lead placement and one or more of the above pacing indications.

The Medtronic CapSureFix MRI™ SureScan™ 5086MRI lead is indicated for use as a system consisting of a Medtronic Revo MRI™ SureScan™ Model RVDR01 IPG implanted with two SureScan leads. A complete system is required for use in the MRI environment.

This lead has application where implantable dual chamber MR Conditional pacing systems are indicated.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P810025/S028

2/25/11

180-Day

Amvisc® and Amvisc® Plus Ophthalmic Viscosurgical Devices (OVD) Bausch & Lomb, Inc.

Aliso Viejo, CA

92656

Approval for an alternate raw material source and alternate manufacturing site (Lifecore Biomedical, LLC, Chaska, MN) for raw material and finished products.
P830055/S107

2/22/11

180-Day

LCS Total Knee System DePuy Orthopaedics, Inc. Warsaw, IN

46581

Approval to manufacture the P.F.C. Sigma RP-F, LCS Complete RP, and RPS Tibial Inserts from GUR 1020 polyethylene with an antioxidant (AOX), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the P.F.C. Sigma RP-F, LCS Complete RP and RPS Tibial Inserts.
P850048/S024

2/7/11

Special

Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system.

2) Always load a reagent pack before scanning the bar code (Access/

Access 2 only). For specific instructions, consult the system documentation.

P850048/S025

2/4/11

Special

Access® Hybritech® PSA Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P910073/S092

2/11/11

Real-Time

RELIANCE 4-Site Defibrillation Lead Boston Scientific

St. Paul, MN

55112

Approval for a decrease in the length of the polyurethane tubing present at the proximal end of the lead and a labeling note regarding implantation technique.
P950005/S031

2/3/11

180-Day

Celsius RMT Catheter (4mm) Biosense Webster Diamond Bar, CA 91765 Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P950032/S059

2/14/11

135-Day

Apligraf® Organogensis Incorporated

Canton, MA

02021

Approval to use a rapid microbial method, as an alternate sterility testing method for all in-process liquid samples currently tested per United States Pharmacopeia <71>, Sterility Tests.
P950037/S092

2/11/11

Real-Time

Estella DR ;

Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;

Effecta D; Effecta DR; Effecta S; and Effecta SR

Biotronik, Inc.

Lake Oswego, OR 97035

Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The modified devices will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P960013/S063

2/3/11

135-Day

Tendril Leads St. Jude Medical, Inc.

Sylmar, CA

91392

Approval for the use of an alternate supplier for the manufacture of shaft assemblies.
P960022/S007

2/18/11

180-Day

Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses Bausch & Lomb, Inc.

Rochester, NY

14609

Approval for a name change to the currently marketed Bausch & Lomb® SofLens® 66 Toric (alphafilcon A) Visibility tinted Contact Lenses. The proposed name for the device is Bausch & Lomb® SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses.
P970038/S013

2/7/11

Special

Access® Hybritech® Free PSA Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/

Access 2 only). For specific instructions, consult the system documentation.

P970038/S014

2/4/11

Special

Access® Hybritech® Free PSA Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P980018/S011

2/17/11

180-Day

Herceptest™ Kit Dako Denmark A/S Glostrup, Denmark

DK-2600

Approval of the DakoLink v3.1.0. software for Herceptest™ kit.
P980022/S087

2/17/11

135-Day

Paradigm Real Time System Medtronic, Inc. Northridge, CA 91325 Approval of the addition of an alternate vendor for the Dynaroll battery tube.
P980023/S043

2/28/11

Real-Time

Linox smart S and Linox smart T Steroid- Eluting Single Coil ICD Leads Biotronik, Inc.

Lake Oswego, OR

97035

Approval for: 1) addition of Silglide surface treatment of the silicone lead body; 2) increase in outer diameter of lead body at DF-1 connector exit; and 3) additional suppliers for silicone and conductor materials.
P980041/S014

2/7/11

Special

Access® AFP Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval to add the following new warning label to all Access DxI systems. “Warning” Erroneous results can occur if reagent packs are not loaded properly. 1) Never transfer a partial reagent pack that was used on a different system. 2) Always load a reagent pack before scanning the bar code (Access/

Access 2 only). For specific instructions, consult the system documentation.

P980041/S015

2/4/11

Special

Access® AFP Reagents on the Access® Immunoassay Systems Beckman Coulter, Inc.

Chaska, MN

55318

Approval for the following changes: 1) modify the fluidics interconnect panels to add tube clips; 2) additional tubing labels which correspond with fluidic interconnect panel; 3) add strain relief as a bend deterrent; and 4) update maintenance documentation to reflect modified configuration.
P980049/S062

2/10/11

Real-Time

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

Plymouth, MN 5541

Approval for the changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750.
P990025/S026

2/3/11

180-Day

NaviStar RMT Catheter (4mm) Biosense Webster Diamond Bar, CA 91765 Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P000008/S017

2/16/11

Panel-Track

LAP-BAND™ Adjustable Gastric Banding System Allergan, Inc. Goleta, CA

93117

Approval for LAP-BAND™ Adjustable Gastric Banding System. The LAP-BAND™ System is indicated for weight reduction for patients with obesity, with a Body Mass Index (BMI) of at least 40 kg/m 2

or a BMI of at least 30 kg/ m 2 with one or more obesity related comorbid conditions. It is indicated for use in adult patients who have failed more conservative weight reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

P000009/S043

2/11/11

Real-Time

Estella DR ;

Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;

Effecta D; Effecta DR; Effecta S; and Effecta SR

Biotronik, Inc.

Lake Oswego, OR 97035

Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P000018/S044

2/23/11

180-day

Beta-Cath™ System Best Vascular, Inc. Norcross, GA

30093

Approval of the post-approval study protocol.
P010013/S032

2/18/11

135-Day

NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.

Marlborough, MA

01752

Approval for a change to the molded manifold component to require the component to be annealed.
P010030/S024

2/18/11

Real-Time

LifeVest Wearable Defibrillators Zoll Lifecor Corporation

Pittsburgh, PA

15238

Approval for software changes including asystole notification handling, low battery notification handling, and power up response button sequence in addition to labeling updates resulting from those changes.
P010032/S036

2/11/11

Real-Time

Eon Neurostimulation (IPG) System St. Jude Medical

Plano, Texas

75024

Approval for adding heat shrink tubing to the conductors of the coaxial cable of the Charging Antenna which is used with the Eon IPG System.
P010032/S037

2/24/11

Real-Time

Eon Neurostimulation (IPG) System St. Jude Medical

Plano, Texas

75024

Approval for antenna spacer disks for the Model 3701 Eon wall charger kit.
P010047/S001

2/17/11

180-Day

NeoMend ProGEL Pleural Air Leak Sealant Neomend, Inc.

Irvine, CA

92618

Approval of the post-approval study protocol.
P010068/S021

2/3/11

180-Day

NaviStar RMT DS Catheter (8mm) Biosense Webster Diamond Bar, CA 91765 Approval for a manufacturing site located at Biosense Webster, Inc, Juarez, Mexico.
P020014/S032

2/24/11

Real-Time

Conceptus Essure® System for Permanent Birth Control Conceptus, Inc. Mountain View, CA

94041

Approval for design changes to the duckbill valve of the valved introducer and changes to the length of the delivery wire.
P020026/S026

2/22/11

180-Day

4.00mm CYPHER® Sirolimus-Eluting Coronary Stent on RAPTORRAIL® Rapid Exchange (RX) Delivery System Cordis Corporation Miami, FL

33102

Approval for the 4.0mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® (RX) Delivery System. The device, as modified will be marketed under the trade name 4.00mm CYPHER® Sirolimus-eluting Coronary Stent on RAPTORRAIL® Rapid Exchange Delivery System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic disease due to discrete de novo lesions of length ≤ 30 mm in native coronary arteries with a reference vessel diameter of ≥ 2.25 to ≤ 4.0 mm.
P020036/S016

2/14/11

Real-Time

SMART Nitinol Stent System and SMART Control Nitinol Stent System Cordis Corporation Bridgewater, NJ

08807

Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems.
P020047/S023

2/3/11

135-Day

 

 

MULTI-LINK - 8™, MULTI-LINK - 8™ LL, and MULTI-LINK - 8™ SV Coronary Stent Systems Abbott Vascular

Temecula, CA

92590

Approval for: 1) the addition of sensors for monitoring the coating process; and 2) minor tooling upgrades.
P030024/S014

2/28/11

135-Day

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc. Cardiff, United Kingdom Approval for a change in the manufacturing scale for a component reagent.
P030047/S019

2/14/11

Real-Time

PRECISE, PRECISE Rx, and PRECISE PRO Rx Nitinol Stent Systems Cordis Corporation Bridgewater, NJ

08807

Approval for a change in colorant used in the catheters of the PRECISE and SMART Nitinol Stent Systems.
P030054/S155

2/11/11

Real-Time

DSA0006 Slit Suture Sleeve Accessory St. Jude Medical

Sylmar, CA

91342

Approval for a new 4.3-4.7 Fr slit suture sleeve accessory kit to be used with the approved 1258T Quickflex μ lead.
P040006/S005

2/8/11

Special

In Motion® Lumbar Artificial Disc DePuy Spine, Inc. Raynham, MA 02767 Approval for the change in tolerance of the implant dimensions and the subsequent independent inspection of these dimensions.
P040043/S037

2/24/11

180-Day

GORE TAG Thoracic Endoprosthesis W.L. Gore and Associates, Inc. Flagstaff, AZ

86001

Approval to update the GORE TAG Thoracic Endoprosthesis instructions for use to include summary information on the evaluation of the physician training program for this device.
P040050/S007

2/4/11

180-Day

Macroplastique Implants Uroplasty, Inc.

Minnetonka, MN

55343

Approval for a contract gamma sterilization site located at Steris/Isomedix Contract Sterilization Services, Libertyville, Illinois.
P050010/S008

2/16/11

Real-Time

ProDisc-L Total Disc Replacement Synthes Spine

West Chester, PA

19380

Approval for MR Conditional Labeling.
P050023/S041

2/11/11

Real-Time

Estella DR ;

Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;

Effecta D; Effecta DR; Effecta S; and Effecta SR

Biotronik, Inc.

Lake Oswego, OR 97035

Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P050034/S004

2/4/11

Real-Time

Implantable Miniature Telescopes™ (IMT) VisionCare Ophthalmic Technologies Saratoga, CA

95070

Approval for extending the shelf life of the IMT from 2 years to 3 years.
P050044/S016

2/4/11

Special

Vitagel Surgical Hemostat Orthovita, Inc. Malvern, PA

19355

Approval for an additional in- process inspection of the Transfer Syringes to visually check that the caps are present and appropriately tightened.
P060019/S009

2/23/11

180-Day

Safire BLU and Therapy Cool Path Bi-Directional Ablation Catheters St. Jude Medical Irvine, CA

92614

Approval to add bi-directional steering to the Therapy Cool Path Ablation Catheter. The devices, as modified, will be marketed under the trade names Safire BLU Irrigated Ablation Catheter and Therapy Cool Path Ablation Catheter.
P060027/S029

2/10/11

Real-Time

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

Plymouth, MN

55441

Approval for changes to the transformer, Opto Wedge, and Desiccant for the Paradym ICD and CRT-D Models 8250, 8550, and 8750.
P070001/S009

2/16/11

Real-Time

ProDisc-C Total Disc Replacement Synthes Spine

West Chester, PA

19380

Approval for MR Conditional Labeling.
P070008/S021

2/11/11

Real-Time

Estella DR ;

Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T;

Effecta D; Effecta DR; Effecta S; and Effecta SR

Biotronik, Inc.

Lake Oswego, OR 97035

Approval for the ICS 3000 Programmer Application Software Version PSW 1004.U. The devices, as modified will be marketed under the following tradenames: the Estella DR; Estella DR-T; Estella SR; Estella SR-T; Ecuro DR; Ecuro DR-T; Ecuro SR; Ecuro SR-T; Effecta D; Effecta DR; Effecta S; and Effecta SR.
P070015/S046

2/3/11

135-Day

XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.

Temecula, CA

92591

Approval for changes to the testing plan for the drug substance.
P080013/S003

2/18/11

180-Day

DuraSeal Spine Sealant System Covidien

Bedford, MA

01730

Approval for the replacement of the current DuraSeal Spine Sealant polyethylene glycol (PEG) formulation with a lower molecular weight formulation.
P080015/S003

2/3/11

Real-Time

Cervista HPV 16/18 Hologic, Inc.

Marlborough, MA 01752

Approval for several changes to the Cervista HPV 16/18 software and labeling. Changes include numerous user interface changes, and separating the Invader Call Reporter and Cervista HPV 16/18 software on to separate CDs with new part numbers.
P080027/S001

2/18/11

Panel-Track

OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc. Bethlehem, PA 18015 Approval for the OraQuick® HCV Rapid Antibody Test. The device is a single-use immunoassay for the qualitative detection of antibodies to hepatitis C virus (anti-HCV) in fingerstick whole blood specimens and venipuncture whole blood specimens (EDTA, sodium heparin, lithium heparin, and sodium citrate) from individuals 15 years or older. The OraQuick® HCV Rapid Antibody Test results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with HCV (state of infection or associated disease not determined) in persons with signs or symptoms of hepatitis and in persons at risk for hepatitis C infection.
P080032/S004

2/4/11

180-Day

Alair Bronchial Thermoplasty System Boston Scientific Corporation

St. Paul, MN

55112

Approval for adding gamma irradiation as an alternative sterilization method, establishing expiration dating for that sterilization method, and adding Sterigenics (Hayward, California) as a contract sterilizer.
P090003/S005

2/3/11

135-Day

Express® LD Iliac Pre-mounted Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Approval for multiple component-specific manufacturing process changes.
P090006/S002

2/15/11

180-Day

Complete SE Vascular Stent System Medtronic Vascular Santa Rosa, CA

95403

Approval for the 120mm length Complete SE Vascular Stent.
P090022/S004

2/2/11

Real-Time

Softec HD PS Posterior Chamber Intraocular Lens (PCIOL) Lenstec, Inc.

St. Petersburg, FL 33716

Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18.0 through 25.0 diopters to 15.0 through 25.0 diopters. The device, as modified, will be marketed under the trade name Softec HD PS Posterior Chamber Intraocular Lens (PCIOL) and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.

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
N16895/S092

2/9/11

Bausch & Lomb SofLens (polymacon) Visibility Tinted Contact Lenses Bausch & Lomb, Inc.

Rochester, NY

14609

Change in supplier location.
N18033/S051

2/14/11

VISTAKON® (etafilcon A) Soft Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Implementation of an alternate test method for determining the purity in the raw material, N,N-Dimethyacrylamide, used in the VISTAKON® (etafilcon A) Soft Contact Lenses.
N18033/S052

2/14/11

VISTAKON® (etafilcon A) Soft Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Implementation of an automated process for verifying lot data prior to printing labels for VISTAKON® (etafilcon A) Contact Lenses.
N18033/S053

2/14/11

VISTAKON® (etafilcon A) Soft Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Implementation of an alternate test method for determining the purity in the raw material, Methacrylic Acid, used in the VISTAKON® (etafilcon A) Soft Contact Lenses.
P810002/S072

2/7/11

St. Jude Medical Mechanical Heart Valve St. Jude Medical

St. Paul, MN

55117

Change in gel fixation time.
P880086/S197

2/23/11

Affinity, Integrity, Victory, Zephyr, and Accent Families of Pacemakers St. Jude Medical, Inc.

Sylmar, CA

91342

Change to the setscrew and septum installation process.
P890003/S212

2/24/11

Prodigy Family of IPGs Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P910001/S043

2/3/11

 

ELCA Coronary Atherectomy Catheters Spectranetics Corporation

Colorado Springs, CO

80921

Use of additional pouch sealing equipment.
P910001/S044

2/28/11

 

ELCA Coronary Atherectomy Catheters Spectranetics Corporation

Colorado Springs, CO

80921

Modifications to the glass preform process.
P930038/S065

2/18/11

Angio-Seal™ Vascular Closure Device St. Jude Medical

St. Paul, MN

55117

Reduction in the frequency of an in- process quality control inspection.
P950022/S076

2/10/11

Durata Family of Leads St. Jude Medical Sylmar, CA

91342

Use of an alternate supplier for a lead component.
P950032/S062

2/10/11

Apligraf Organogenesis, Inc. Canton, MA

02021

Alternate supplier for the polycarbonate base film used in the manufacture of a culture insert.
P960042/S025

2/9/11

Spectranetics Laser Sheath II (SLS II) Spectranetics Corporation

Colorado Springs, CO

80921

Change to the fusing process for the outer jacket tubing.
P960042/S026

2/28/11

 

Spectranetics Laser Sheath II (SLS II) Spectranetics Corporation

Colorado Springs, CO

80921

Modifications to the glass preform process.
P970003/S120

2/17/11

VNS Therapy® System Cyberonics, Inc.

Houston, TX

77058

Addition of alternate raw materials and removal of associated cleaning steps.
P970003/S121

2/28/11

VNS Therapy® System Cyberonics, Inc.

Houston, TX

77058

Change to the pulse generator manufacturing process.
P970012/S082

2/24/11

Kappa 400 Family of IPGs Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P970021/S032

2/16/11

 

Gynecare Thermachoice III Uterine Balloon Therapy System ETHICON, Inc. Somerville, NJ

08876

Use of a new sub- tier supplier for the printed circuit board assembly.
P970021/S033

2/25/11

Gynecare Thermachoice III Uterine Balloon Therapy System ETHICON, Inc.

Somerville, NJ

08876

Change in the cleaning solution used in removing residue from the heating wire during the manufacturing process.
P980016/S274

2/3/11

Virtuoso, Secura DR/VR, Maximo II DR/VR, and Virtuoso II VR/DR ICDs Medtronic, Inc.

Mounds View, MN

55112

Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process.
P980016/S275

2/10/11

Maximo II DR /VR, Virtuoso II DR/VR and Secura DR/VR Medtronic, Inc. Mounds View, MN 55112 Updates to test software used during final functional device testing.
P980016/S276

2/17/11

Maximo II DR /VR, Virtuoso II DR/VR, Secura DR/VR, Virtuoso, EnTrust, Marquis, Maximo and Intrinsic Families of ICDs Medtronic, Inc. Mounds View, MN 55112 Implementation of a detection step in the battery manufacturing process at a supplier.
P980016/S277

2/24/11

Entrust, Intrinsic, Marquis, Maximo, Maximo II, Secura, Virtuoso and Virtuoso II Families of ICDs Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P980016/S279

2/23/11

Entrust ICD, Intrinsic, Marquis, Maximo, Maximo ICD, Maximo II DR/VR, Secura DR/VR ICD, Virtuoso ICD, Virtuoso II DR/VR ICD Medtronic, Inc. Mounds View, MN 55112 Automation of an additional plating line.
P980018/S012

2/11/11

HercepTest™ Dako Denmark A/S Glostrup, Denmark Automated filling of DAB chromogen for HercepTest™ as the primary filling process.
P980035/S201

2/24/11

Medtronic 350 Series, Adapta, AT500, EnPulse, EnRhythm, Kappa 700/800/900, Relia, Sensia, Sigma, and Versa Families of IPGs Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P980035/S202

2/23/11

Adapta, Versa, Sensia, EnRhythm, Relia IPGs Medtronic, Inc. Mounds View, MN 55112 Automation of an additional plating line.
P990001/S083

2/24/11

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

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P990001/S084

2/23/11

Vitatron DA+ C-Series, and

DA+ T-Series Families of IPGs

Medtronic, Inc. Mounds View, MN 55112 Automation of an additional plating line.
P990020/S044

2/7/11

AneuRX AAAdvantage Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Change to sample numbers for Endotoxin Testing and a lot definition change.
P000037/S022

2/16/11

On-X® Prosthetic Heart Valve On-X Life Technologies, Inc. Added production capability for two currently outsourced machining processes.
P000039/S039

2/18/11

AMPLATZER® Septal Occluder AGA Medical Corporation

Plymouth, MN

55442

Use of new patch forming equipment.
P010001/S008

2/25/11

Ceramic TRANSCEND® Hip Articulation System CeramTec GmbH

Plochingen, Germany

Addition of two “like to like” machines used for the following manufacturing processes of the ceramic ball heads: 1) grinding the inner bore and chamfer; and 2) polishing the outer ball head contour.
P010015/S108

2/24/11

InSync and InSync III Families of CRT-Ps Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P010031/S229

2/3/11

Consulta, Consulta II, Maximo II and Concerto CRT-Ds Medtronic, Inc.

Mounds View, MN 55112

Reduction in the frequency of a quality control test for the Laser Ribbon Bonding (LRB) process.
P010031/S230

2/10/11

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

Mounds View, MN 55112

Updates to test software used during final functional device testing.
P010031/S231

2/17/11

Concerto II, Maximo II, Consulta, Concerto, InSync Maximo, InSync Sentry, InSync II Marquis, and InSync III Marquis Families of CRT-Ds Medtronic, Inc. Mounds View, MN 55112 Implementation of a detection step in the battery manufacturing process at a supplier.
P010031/S233

2/24/11

Concerto, Concerto II, Consulta, InSync II Marquis, InSync III Marquis, InSync Maximo, InSync Sentry and Maximo II Families of CRT-Ds Medtronic, Inc.

Mounds View, MN

55112

Revision of parameters to an epoxy dispense manufacturing process.
P010031/S235

2/23/11

Concerto CRT-D, Concerto II ICD, Consulta CRT-D, InSync II Marquis, InSync II Protect, InSync III Marquis, InSync Maximo, InSync Sentry, Maximo II CRT-D Medtronic, Inc. Mounds View, MN 55112 Automation of an additional plating line.
P010047/S008

2/10/11

NeoMend ProGel™ Surgical Sealant NeoMend, Inc. Irvine, CA

92618

Packaging of ProGel™ Applicator Spray Tips as an accessory separately from the NeoMend Pleural Air Leak Sealant Device.
P020004/S058

2/18/11

GORE® EXCLUDER® AAA Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Automation for crimping gold marker bands.
P020024/S031

2/18/11

AMPLATZER® Duct Occluder, AMPLATZER® 1800 Delivery and Exchange System AGA Medical Corporation

Plymouth, MN

55442

Use of new patch forming equipment.
P020056/S013

2/11/11

Natrelle Silicone-Filled Breast Implants Allergan

Goleta, CA

93117

Change in the tubing used in the gel filling process.
P030011/S010

2/18/11

SynCardia Temporary Total Artificial Heart (TAH-t) System SynCardia Systems, Inc.

Tuscon, AZ

85713

Relocation of several critical manufacturing operations from one building to another within the same corporate complex.
P030035/S077

2/23/11

Frontier, Frontier II, and Anthem Families of CRT-Ps St. Jude Medical, Inc.

Sylmar, CA

91342

Change to the setscrew and septum installation process.
P040014/S016

2/17/11

Therapy Cardiac Ablation Catheter St. Jude Medical, Inc.

Irvine, CA

92614

Implementation of an additional test system for electrical testing.
P040037/S034

2/16/11

Gore VIBAHN® Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AR

86001

Duplication of a manufacturing process at an alternate building within the same complex.
P040037/S035

2/18/11

Gore VIABAHN® Endoprosthesis W.L. Gore & Associates, Inc.

Flagstaff, AR

86001

Duplication of a similar manufacturing process at an alternate location.
P040040/S016

2/18/11

Amplatzer® Muscular VSD Occluder AGA Medical Corporation

Plymouth, MN

55442

Use of new patch forming equipment.
P040042/S021

2/17/11

Therapy Dual 8, Therapy and Safire TX Ablation Catheters St. Jude Medical, Inc.

Irvine, CA

92614

Implementation of an additional test system for electrical testing.
P050006/S019

2/18/11

GORE® HELEX Septal Occluder W.L. Gore & Associates, Inc.

Flagstaff, AZ

86001

Addition of alternate powder for the manufacturing of the Occluder.
P050028/S013

2/24/11

COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 for use with The High Pure System Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.0 within the FDA approved PCR Manufacturing Center (PMC) facility in Branchburg, New Jersey.
P050042/S009

2/17/11

ARCHITECT Anti-HCV Abbott Laboratories Abbott Park, IL

60064

Change in the vendors for antifoam and goat serum, and a change in a material test method.
P050044/S017

2/25/11

Vitagel Surgical Hemostat Orthovita Incorporated

Malvern, PA

19355

Addition of an alternate location for conducting two microbiological assays used in the manufacture of the Vitagel Surgical Hemostat.
P060002/S017

2/16/11

FLAIR® Endovascular Stent Graft C.R. Bard, Inc. Tempe, AZ

85281

Changes to the manufacturing data access and storage software systems.
P060019/S017

2/17/11

Therapy Cool Path Ablation Catheter St. Jude Medical, Inc.

Irvine, CA

92614

Implementation of an additional test system for electrical testing.
P060030/S15

2/24/11

COBAS TaqMan HCV Test, v2.0 for use with The High Pure System Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Elimination of the in-process chemical testing of the Buffer Concentrate component of the Master Mix used with the COBAS TaqMan HCV Test, v2.0.
P060038/S009

2/3/11

Mitroflow® Aortic Pericardial Heart Valve Sorin Group USA, Inc.

Arvada, CO

80004

Addition of a supplier of a device component.
P070007/S027

2/7/11

Talent Thoracic Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Change to sample numbers for Endotoxin Testing and a lot definition change.
P070022/S010

2/16/11

Adiana Permanent Contraception System GYN-Surgical Products

Marlborough, MA

01752

Change to the work instructions for the fluid filling process of the damper subassembly.
P070027/S028

2/7/11

Abdominal Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Change to sample numbers for Endotoxin Testing and a lot definition change.
P100021/S001

2/7/11

Endurant Stent Graft System Medtronic Vascular

Santa Rosa, CA

95403

Change to sample numbers for Endotoxin Testing and a lot definition change.

Summary of PMA Originals & Supplements Approved

Originals: 2

Supplements: 54

Summary of PMA Originals Under Review

Total Under Review: 97

Total Active: 49

Total On Hold: 48

Number Greater Than 180 Days: 5

Summary of PMA Supplements Under Review

Total Under Review: 681

Total Active: 474

Total On Hold: 207

Number Greater Than 180 Days: 12

Summary of All PMA Submissions Received

Originals: 4

Supplements: 82

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 54

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 173.2

FDA Time: 111.5 Days MFR Time: 61.7 Days

SOURCE

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