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U.S. Department of Health and Human Services

Medical Devices

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February 2012 PMA Approvals

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.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P080012
2/7/12
Prometra Programmable Infusion Pump System Medasys, Incorporated
Mount Olive, NJ
07828
Approval for the Prometra Programmable Infusion Pump System. The device is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (Sodium Chloride Injection, USP).
P100007
2/10/12
Breast Companion® Software System Almen Laboratories, Inc.
Vista, CA
92084
Approval for the Breast Companion® Software System. The Breast Companion® is a computer-aided system intended for improving the ACR BI-RADS assessment of ultrasound images of lesions of the female breast as part of the diagnostic workshop.
P100025
2/22/12
BreathTek UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0 Otsuka America Pharmaceutical, Inc.
Rockville, MD
20850
Approval for the BreathTek
UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0. This device is indicated for:
The BreathTek UBT for H pylori Kit (BreathTek UBT Kit) is intended for use in the qualitative detection of urease associated with H. pylori in the human stomach and is indicated as an aid in the initial diagnosis and post-treatment monitoring of H. pylori infection in adults, and pediatric patients 3 to 17 years old. The test may be used for monitoring treatment if used at 4 weeks following completion of therapy. For these purposes, the system utilizes an Infrared Spectrophotometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples, in clinical laboratories and point-of-care settings. The Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. The BreathTek UBT Kit is for administration by a health care professional, as prescribed by a physician.
P100033
2/13/12
PROGENSA® PCA3 Assay Gen-Probe Incorporated
San Diego, CA
92121
Approval for the PROGENSA® PCA3 Assay. This device is indicated for: PROGENSA® PCA3 Assay is an in vitro nucleic acid amplification test. The assay measures the concentration of prostate cancer gene 3 (PCA3) and prostate-specific antigen (PSA) RNA (RNA) molecules and calculates the ratio of PCA3 RNA molecules to PSA RNA molecules (PCA3 Score) in post digital rectal exam (DRE) first catch male urine specimens. The PROGENSA® PCA3 Assay is indicated for use in conjunction with other patient information to aid in the decision for repeat biopsy in men 50 years of age or older who have had one or more previous negative prostate biopsies and for whom a repeat biopsy would be recommended by a urologist based on current standard of care, before consideration of PROGENSA® PCA3 Assay results.
A PCA3 score <25 is associated with a decreased likelihood of a positive biopsy. Prostatic biopsy is required for diagnosis of cancer.
P110013
2/17/12
Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System and Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic Vascular, Inc.
Santa Rosa, CA
95403
Approval for the Resolute MicroTrac Zotarolimus-Eluting Coronary Stent System and Resolute Integrity Zotarolimus-Eluting Coronary Stent Systems. These devices are indicated for improving coronary luminal diameters in patients, including those with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions of length 27 ≤ mm in native coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm.
P110028
2/22/12
Absolute Pro® Vascular Self-Expanding Stent System Abbott Vascular
Santa Clara, CA
95054
Approval for the Absolute Pro® Vascular Self-Expanding Stent System. The device is indicated for improving luminal diameter in patients with de novo or restenotic atherosclerotic lesions in the native common iliac artery and native external iliac artery with reference vessel diameters between 4.3 mm and 9.1 mm and lesions lengths up to 90 mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18033/S061
2/1/12
135-Day
VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Approval for the implementation of an alternate test method for determining the purity of the raw materials used in reactive monomer mix formulation.
N18286/S022
2/29/12
Real-Time
Gelfoam (absorbable gelatin) Sterile Sponge Pfizer, Inc.
New York, NY
10017
Approval for a new convenience kit, Gelfoam Plus – Powder to be comprised of Gelfoam Powder, human thrombin, one syringe that is pre-filled with 0.9% NaC1 solution, one empty syringe, a needleless transfer device and an applicator tip.
P820076/S025
2/24/12
135-Day
Diplos Dual Chamber Pacing Systems Biotronik, Inc.
Lake Oswego, OR
97035
Approval for addition of an automated production test process.
P830037/S053
2/7/12
180-Day
FreshLook® UV Spherical and FreshLook® Toric CIBA VISION Corporation
Duluth, GA
30097
Approval for the use of the new Phoenix VT print pads used to transfer inks onto the lens surface and for the addition of a pre-conditioning step for optimal ink adhesion onto the lenses when the new print pad is utilized.
P830055/S121
2/9/12
Real-Time
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of mobile bearing Attune CR (cruciate retaining) RP (rotating platform) tibial bases and tibial inserts for use with previously cleared femoral and patellar components. The device, as modified, will be marketed under the trade name Attune Rotating Platform (RP) Total Knee System and is indicated for use in total knee replacement in patients with a severely painful and/or severely disabled joint resulting from osteoarthritis, post-traumatic arthritis, rheumatoid arthritis, or a failed previous implant.
P830055/S122
2/6/12
Real-Time
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for the addition of TruMatch Patient Specific Instruments (patient-matched cutting/drilling guides) as optional instrumentation to use with femoral and tibial components.
P830055/S125
2/21/12
LCS Total Knee System DePuy Orthopaedics, Inc.
Warsaw, IN
46581
Approval for additional inspection steps to the manufacturing process of the Sigma PS Femoral Components, Sigma PS Femoral Components with Lugs and Sigma RPF Femoral Components.
P850048/S026
2/17/12
Real-Time
Access Hybritech PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P860004/S161
2/16/12
135-Day
SynchroMed II Infusion Pump Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for automating the transfer of endotoxin testing data into the FACTORY works execution system.
P860004/S167
2/17/12
Real-Time
Indura 1 Piece Intrathecal Catheter with Sutureless Connector, Intrathecal Catheter with Sutureless Connector, Intrathecal Catheter Pump Segment Revision Kit with Sutureless Connector, Sutureless Pump Connector Revision Kit for Intrathecal Catheters Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for the Sutureless Connector (SC) catheter Models 8709SC and 8731SC, and revision kit Models 8578 and 8596SC to address the potential for side load leaks. The modifications to your sutureless connector are as follows:
1) decreased the counter bore diameter from 0.040" to 0.035" ;
2) decreased the depth of the counter bore from 0.055" to 0.050" ; 3) increased the tolerance for the 0.15" dimension of the tubing position from ± 0.01to ± 0 .0 2; and 4) added a requirement to the product specification for side load forces: Connecto r must not occlude or leak when pressurized to 1.0 ± 0.1 psig air pressure and a force of 4.8 ± 0.1 l bf is distributed over the connector surface at an angle of 12° ± 2° .
P860047/S025
2/3/12
180-Day
OcuCoat (2% Hydroxypropyl-
methylcellulose) Syringe Product
Bausch & Lomb, Inc.
Aliso Viejo, CA
92656
Approval for an alternate elastomeric tip cap material (FM27) and the addition of a threaded Plastic Rigid Tip Cap (PRTC) outer shell.
P910001/S051
2/17/12
135-Day
Excimer Laser Coronary Atherectomy (ELCA) Catheters Spectranetics Corporation
Colorado Springs, CO
80921
Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.
P910065/S008
2/13/12
180-Day
ST AIA-PACK PA Tosoh Bioscience, Inc.
South San Francisco, CA
94080
Approval for the addition of one FDA-cleared Tosoh Automated Immunoassay Analyzer, the AIA-900, for use with the ST AIA-PACK PA assay.
P950005/S033
2/8/12
135-Day
CELSIUS® and CELSIUS® II Diagnostic/Ablation Deflectable Tip Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for an increase in the number of allowed EtO sterilization cycles, and a modification to the workmanship inspection performed by Quality Control.
P950032/S067
2/22/12
Real-Time
Apligraf (Graftskin) Organogenesis, Inc.
Canton, MA
02021
Approval for the introduction of Human Epidermal Keratinocyte cell strain (HEP 158) into the manufacture of the device.
P950034/S040
2/17/12
135-Day
Seprafilm Adhesion Barrier Genzyme Corporation
Framingham, MA
01701
Approval for implementing a new compressed air system.
P950037/S097
2/24/12
135-Day
Dromos DR/SR Rate Adaptive Pacing Systems Biotronik, Inc.
Lake Oswego, OR
97035
Approval for addition of an automated production test process.
P950042/S007
2/2/12
180-Day
PINPOINT Endoscopic Light Source and Video Camera Novadaq Technologies, Incorporated
Richmond, British Columbia, Canada
V6V 2A2
Approval for a change in the trade name of the medical device from PINPOINT to ONCO-LIFE Endoscopic Light Source and Video Camera.
P960009/S134
2/3/12
Real-Time
Deep Brain Stimulation (DBS) Extension Kits Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for removal of the tunneling tool and tunneling tool accessories from Deep Brain Stimulation (DBS) extension kits, Models 7472A and 37085.
P960042/S032
2/17/12
135-Day
Spectranetics Laser Sheaths (SLS) Spectranetics Corporation
Colorado Springs, CO
80921
Approval for the use of a new sterilization chamber, new sterilization cycle, change in packaging configuration for sterilization, and a change in the sterile load configuration.
P970008/S060
2/3/12
Real-Time
Urologix Targis® System Urologix, Inc.
Minneapolis, MN
55447
Approval for minor changes to the software for the Targis® System CoolWave® Control Unit Model 5000 and associated changes to the User Manual. The device, as modified, will be marketed under the trade name Urologix Targis® System and is indicated for the relief of symptoms and obstructions associated with Benign Prostatic Hyperplasia (BPH) for men with prostatic urethral lengths of 2.5-3.5cm (short antenna), or 3.0-5.0cm (standard antenna), or 4.5+cm (long antenna).
P970029/S014
2/22/12
180-Day
TMR2000 Holmium Laser System Cardiogenesis Corporation
Kennesaw, GA
30144
Approval for the PEARL 8.0 handpiece.
P970038/S015
2/17/12
Real-Time
Access Hybritech Free PSA Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P970051/S089
2/28/12
Real-Time
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO
80111
Approval for the CP800 Series Soft Earhook, which is an accessory to the CP810 Sound Processor that acts as an alternative to the currently marketed CP800 Series Earhook.
P980003/S034
2/15/12
Real-Time
Chilli Cooled Ablation System – CircuCool Pump Boston Scientific Corporation
San Jose, CA
95134
Approval for five changes to address the failure of a micro switch designed to automatically shut off the pump if the roller bed cover is opened without turning off the power switch. These changes include:
1) Introducing a new micro switch which features an auxiliary actuator which eliminates direct contact between the retainer screw and the actuator button; 2) Adding a secondary shoulder on the retainer screw to limit the screw penetration depth to coincide with the tolerance stack up with the micro switch position;
3) Minor dimension and tolerance changes to the mounting plate to accommodate the new micro switch; 4) Use “counter-sink” holes instead of “straight-through” holes in the pump head to secure the mounting plate, ensuring bracket alignment and minimizing “play” in the bracket installation; and
5) Adding an inspection step and test fixture to verify the installed position of the micro switch relative to the pump head.
P980022/S107
2/6/12
Real-Time
iPro2 Professional Continuous Glucose Monitoring System Medtronic, Inc.
Northridge, CA
91325
Approval for software changes to the CareLink iPro Therapy Management Software (MMT-7340, version 1.4A) for use with the device.
P980023/S046
2/22/12
180-Day
Vigila and Volta Defibrillation Leads Biotronik, Inc.
Lake Oswego, OR
97035
Approval for the following:
1) addition of trade names Vigila and Volta for the Linox and Linox smart defibrillation leads; 2) change to Indications for Use statement to clarify that the Vigila and Volta leads may be used with any manufacturers' ICDs; and 3) accessory kits for use with the Vigila and Volta leads.
P980024/S006
2/27/12
135-Day
PathVysion HER-2 DNA Probe Kit Abbott Molecular, Inc.
Des Plaines, IL
60018
 
Approval for manufacturing process changes to the PathVysion HER-2 DNA Probe Kit, including changes associated with FISH probe restriction enzyme digested gel electrophoresis (DNA restriction analysis), implementation of an in-process validated test method for A260 absorbance readings, addition of an incoming screening test for dextran sulfate and revision to manufacturing procedure document for LSI HER-2/neu aminated DNA.
P980041/S016
2/17/12
Real-Time
Access AFP Reagents on the Access Immunoassay Systems Beckman Coulter, Inc.
Chaska, MN
55318
Approval for the change in polypropylene resin used for manufacturing of the reagent pack container.
P990056/S014
2/24/12
180-Day
Elecsys Total PSA (tPSA) Test System Roche Diagnostics
Indianapolis, IN
46250
Approval for extension of the Elecsys Total PSA (tPSA) test system onto the cobas e 602 immunoassay analyzer.
P000006/S024
2/13/12
Real-Time
Titan Inflatable Penile Prosthesis Coloplast Corporation
Minneapolis, MN
55411
Approval for: 1) a change in the angle of the tubing on the cylinder from the current 45° to 0° angle to improve the ease of implantation; and 2) to change the tip material from dipped-on Bioflex to bonded-on MED 4750.
P000027/S012
2/24/12
180-Day
Elecsys Free PSA (fPSA) Test System Roche Diagnostics
Indianapolis, IN
46250
Approval for extension of the Elecsys Free PSA (fPSA) test system onto the cobas e 602 immunoassay analyzer.
P000037/S024
2/17/12
135-Day
On-X Prosthetic Heart Valve On-X Life Technologies
Austin, TX
78752
Approval for relocating a sealing machine from a contract manufacturer to in-house.
P000041/S011
2/27/12
180-Day
ClearRead™ Detect Riverain Medical Group, LLC
Miamisburg, OH
45342
Approval to market the device under the additional trade name ClearRead Detect.
P010001/S010
2/14/12
135-Day
Trascend Hip Articulation System CeramTec GmbH
Ferndale, MI
48220
Approval for the addition of an alternate polishing machine at the Plochingen, Germany facility.
P010012/S280
2/16/12
Real-Time
LV-1 Lead Port Plug Boston Scientific Corporation
St. Paul, MN
55112
Approval for a shelf life extension from 4 years to 5 years for the subject LV-1 lead port plug.
P010014/S033
2/3/12
Special
Oxford® Partial Knee System Biomet Manufacturing Corporation
Warsaw, IN
46581
Approval for an additional labeling piece entitled “Oxford Partial Knee X-Ray Protocol”.
P010068/S023
2/8/12
135-Day
NAVISTAR® Dual Sensor 8mm Diagnostic/Ablation Deflectable Tip Catheter Biosense Webster, Inc.
Diamond Bar, CA
91765
Approval for an increase in the number of allowed EtO sterilization cycles, and a modification to the workmanship inspection performed by Quality Control.
P020012/S006
2/9/12
180-Day
Artefill PMMA Collagen Dermal Filler Suneva Medical, Inc.
San Diego, CA
92121
Approval for a manufacturing site located at Suneva Medial, Inc. in San Diego, California.
P020014/S017
2/24/12
180-Day
Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval to modify the existing RF energy warning to add an Essure/ NovaSure warning. Additionally, the PMA supplement includes approval of a post-approval study.
P020014/S033
2/22/12
180-Day
 
Essure System for Permanent Birth Control Conceptus, Inc.
Mountain View, CA
94041
Approval for an alternate hydrophilic coating of the delivery catheter.
P030005/S081
2/16/12
Real-Time
LV-1 Lead Port Plug Boston Scientific Corporation
St. Paul, MN
55112
Approval for a shelf life extension from 4 years to 5 years for the subject LV-1 lead port plug.
P030017/S124
2/1/12
135-Day
Precision® Spinal Cord Stimulator System Boston Scientific Neuromodulation
Valencia, CA
91355
Approval for Ethylene Oxide sterilization equipment and its associated sterilization cycles.
P030025/S086
2/22/12
Panel-Track
TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN
55311
Approval to expand the labeled indications for the TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System. The TAXUS Express 2 Paclitaxel-Eluting Coronary Stent System is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions ≤ 28 mm in length; 2) in patients undergoing primary angioplasty to treat acute ST-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting
> 20 minutes and
< 12 hours in duration; or
3) within bare metal stent restenotic lesions 2.50 mm to 3.75 mm in diameter and ≤ 28 mm in length.
P040044/S039
2/13/12
135-Day
Mynx Vascular Closure Device Product Family Access Closure, Inc.
Mountain View, CA
94043
Approval for modifications to the balloon tube necking process.
P040045/S026
2/1/12
135-Day
VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Approval for the implementation of an alternate test method for determining the purity of the raw materials used in reactive monomer mix formulation.
P050034/S006
2/23/12
Real-Time
Implantable Miniature Telescope™ VisionCare Ophthalmic Technologies
Saratoga, CA
95070
Approval for the addition of the information regarding the safety of the device during MRI exposure to the Patient Information Booklet.
P050043/S006
2/28/12
Real-Time
Femoral Introducer Sheath and Hemostatic Device (FISH), FISH-SP Device Morris Innovative, Inc.
Bloomington, IN
47403
Approval for a new version of the sub-intestinal submucosa (SIS) material (Version 2.0).
P050047/S022
2/24/12
Special
Juvèderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval for the addition of a new Precaution Statement: “Failure to comply with these instructions could result in needle disengagement and/or product leakage at te Luer-lock needle hub connection.”
P060008/S046
2/22/12
Panel-Track
TAXUS Libertè Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN
55311
Approval to expand the labeled indications for the TAXUS Libertè Paclitaxel-Eluting Coronary Stent System. The TAXUS® Libertè® Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire Systems) is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.75 mm to
4.00 mm in diameter in lesions ≤ 34 mm in length; 2) for the treatment of de novo lesions in native coronary arteries 2.25 mm to
2.50 mm in diameter in lesions ≤ 28 mm in length; or 3) in patients undergoing primary angioplasty to treat acute St-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting
> 20 minutes and
< 12 hours in duration.
P060029/S003
2/3/12
180-Day
ETHICON OMNEX Surgical Sealant Ethicon, Inc.
Somerville, NJ
08876
Approval for a manufacturing site located at Ethicon LLC., in San Lorenzo, Puerto Rico.
P070008/S024
2/24/12
135-Day
Stratos LV/LV-T Resynchronization Therapy Pacemaker Systems Biotronik, Inc.
Lake Oswego, OR
97035
Approval for addition of an automated production test process.
P070022/S026
2/9/12
180-Day
Adiana Permanent Contraception System Hologic, Inc.
Marlborough, MA
01752
Approval for a manufacturing site located at Hologic Costa Rica SA., in Alajuela, Costa Rica.
P080011/S009
2/24/12
Special
CooperVision Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Approval for an additional density check of the lens extraction/hydration tanks.
P080025/S022
2/10/12
180-Day
Medtronic InterStim® Therapy System Medtronic Neuromodulation
Minneapolis, MN
55432
Approval for design and specification changes to the Model 3058 InterStim II battery.
P100023/S015
2/22/12
Panel-Track
ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire) Boston Scientific Corporation
Maple Grove, MN
55311
Approval to expand the labeled indications for the ION™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-The-Wire). The ION™ Stent System is indicated for improving luminal diameter: 1) for the treatment of de novo lesions in native coronary arteries 2.25 mm to 4.00 mm in diameter in lesions ≤ 34 mm in length; or 2) in patients undergoing primary angioplasty to treat acute ST-segment elevation myocardial infarction, true posterior myocardial infarction, or presumed new left bundle branch block with symptoms of acute myocardial infarction lasting
> 20 minutes and
> 12 hours in duration.
P100024/S001
2/1/12
Real-Time
HER2 CISH pharmDx™ Kit Dako Denmark A/S
Glostrup, Denmark
DK-2600
Approval for an update of the software documentation for DakoLink software version 3.0 to DakoLink version 3.1.1.
P100027/S002
2/15/12
180-Day
INFORM HER2 Dual ISH DNA Probe Cocktail Assay Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for migration of the INFORM HER2 Dual ISH DNA Probe Cocktail assay to the BenchMark Ultra Auto-stainer. The device, as modified, will be marketed under the trade name INFORM HER2 Dual ISH DNA Probe Cocktail assay and is indicated "for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17.
The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ hybridization (ISH) in formalin-fixed, paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark XT automated slide stainers (using NexES software), or on Ventana BenchMark ULTRA automated slide stainer (using VSS software), by light microscopy. The INFORM HER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom HERCEPTIN (trastuzumab) treatment is being considered.
This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls. This reagent is intended for in vitro diagnostic (IVD) use."

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
P780007/S047
2/10/12
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Additional duplicate dry lines.
P780007/S048
2/9/12
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Addition of a new microbial air sampler and description for bioburden monitoring of the clean room.
P780007/S049
2/9/12
Biomedics 38 (Polymacon) Soft (Hydrophilic) Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Add duplicate equipment for laboratory use.
P810002/S079
2/29/12
St. Jude Medical Mechanical Heart Valve St. Jude Medical, Inc.
St. Paul, MN
55117
Change in X-ray diffraction equipment.
P810031/S042
2/3/12
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV and Healon5 Products Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Implementation of temporary use of an autoclave at the Uppsala, Sweden facility.
P810031/S043
2/15/12
Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV and Healon5 Products Abbott Medical Optics Incorporated
Santa Ana, CA
92705
New supplier for Holders and Rods used in Ophthalmic Viscoelastic Devices.
P840064/S048
2/3/12
DISCOVISC Opthalmic Viscosurgical Devices Alcon Laboratories, Incorporated
Forth Worth, TX
76134
Change in the sterilization process.
P840064/S049
2/1/12
Discovisc Ophthalmic Viscosurgical Device and Duovisc Viscoelastic System Alcon Laboratories, Inc.
Forth Worth, TX
76134
New analytical method for residual solvents.
P850035/S034
2/27/12
SPF PLUS-Mini
(60µA/W) and SpF PLUS-Mini (60µA/M) Implantable Spinal Fusion Stimulators
Biomet, Inc.
Parsippany, NJ
07054
Addition of an alternate supplier of coin cell batteries.
P860057/S085
2/24/12
Carpentier Edwards Perimount Pericardial Endoprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Automated, greater capacity mixing, storage and distribution delivery system.
P880086/S215
2/2/12
Accent Pacemaker Devices St. Jude Medical, CRMD
Sylmar, CA
91342
Alternate supplier for RF electronic assembly modules.
P890047/S036
2/3/12
Provisc Ophthalmic Viscosurgical Devices Alcon Laboratories, Incorporated
Forth Worth, TX
76134
Change in the sterilization process.
P890047/S037
2/1/12
Provisc Ophthalmic Viscosurgical Devices Alcon Laboratories, Inc.
Forth Worth, TX
76134
New analytical method for residual solvents.
P900056/S112
2/29/12
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN
55311
Use of an alternate cleaning agent for the burr preparation process.
P910001/S053
2/24/12
ELCA Coronary Atherectomy Catheters Spectranetics Corporation
Colorado Springs, CO
80921
Remove redundant Quality Control inspection steps in your Fiber Draw and Fiber Re-Spooling manufacturing processes.
P910073/S100
2/29/12
Endotak Reliance S Rx IS-1, Endotak Reliance Ez IS-1, Endotak Reliance 4-Site Ez, Endotak Reliance 4-Site Rx Leads Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P910077/S118
2/29/12
Endotak SQ Array XP Subcutaneous Lead Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P930014/S057
2/16/12
AcrySof Intraocular Lenses Alcon Laboratories, Inc.
Forth Worth, TX
76134
Add a molding system.
P930038/S070
2/15/12
Angio-Seal Vascular Closure Device St. Jude Medical
St. Paul, MN
55114
Removal of a component cleaning step.
P950029/S065
2/2/12
Reply/Esprit SR and DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Additional oven, an updated cleaning process, and an update to the rework process.
P950029/S066
2/16/12
Reply/Esprit SR and DR Pacemaker ELA Medical, Inc. Plymouth, MN
55441
Clean room layout modifications of Saluggia, Italy plant.
P960004/S050
2/29/12
Thinline II Sterox, Fineline II Sterox, Fineline II Sterox Ez Leads Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P960006/S032
2/29/12
Flextend Leads Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P960013/S070
2/23/12
Optisense Lead Tubing St. Jude Medical, Inc.
Sylmar, CA
91342
Eliminate a priming process.
P960042/S034
2/24/12
SLS Spectranetics Laser Sheaths Spectranetics Corporation
Colorado Springs, CO
80921
Remove redundant Quality Control inspection steps in your Fiber Draw and Fiber Re-Spooling manufacturing processes.
P970003/S144
2/1/12
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Three changes to the manufacturing process for the Pulse Generator in the device.
P970003/S145
2/6/12
VNS Therapy System Cyberonics, Inc.
Houston, TX
77058
Introduction of work instructions to allow rework and replacement of components in the device.
P980016/S334
2/29/12
Intrinsic, Marquis DR/VR and Maximo DR/VR ICDs Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P980016/S337
2/29/12
DR Models (Secura, Maximo II, Protecta, Protecta XT) Medtronic, Inc.
Mounds View, MN
55112
Approval for four manufacturing changes: 1) RF Module Solder Flux Clean Addition;
2) Flux Inspection Change; 3) Radio Frequency Device Test Update; and 4) a Manufacturing Site Move for 8-pin filters.
P980035/S257
2/29/12
Adapta, Adapta L, Adapta S, Sensia L, Sensia, Versa Advisa DR, EnRhythm and Relia IPGs Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P980040/S038
2/29/12
TECNIS 1-Piece Lens and TECNIS Multifocal 1-Piece Lens Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Implement a software and hardware upgrade to the equipment used to measure optical properties of intra- ocular lenses.
P980049/S069
2/2/12
Paradym VR and DR Sorin CRM USA, Inc.
Plymouth, MN
55441
Additional oven, an updated cleaning process, and an update to the rework process.
P980049/S070
2/16/12
Paradym VR & DR ICD/CRT-D, Isoline 2CR and 2CT Leads Sorin CRM USA, Inc.
Plymouth, MN
55441
Clean room layout modifications of Saluggia, Italy plant.
P990001/S100
2/29/12
Vitatron IPGs Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P000040/S022
2/14/12
Genesys HTA System Boston Scientific Corporation
Marlborough, MA
01752
Addition of a new supplier in the manufacturing process.
P000040/S023
2/29/12
Genesys HTA System Boston Scientific Corporation
Marlborough, MA
01752
New supplier of several components of the control unit subassemblies.
P000044/S029
2/23/12
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc.
Rochester, NY
14626
Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P010012/S279
2/29/12
Easytrak 2 LV-1 and IS-1, Easytrak 3
LV-1 and IS-1, Acuity Spiral Leads
Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P010015/S152
2/29/12
Consulta and Syncra CRT-Ps Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P010021/S022
2/23/12
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc.
Rochester, NY
14626
Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P010031/S287
2/29/12
InSync III Marquis and InSync Maximo ICDs Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P010031/S290
2/29/12
CRT-D ICD Models (Consulta, Maximo II, Protecta, Protecta XT) Medtronic, Inc.
Mounds View, MN
55112
Approval for four manufacturing changes: 1) RF Module Solder Flux Clean Addition; 2) Flux Inspection Change; 3) Radio Frequency Device Test Update; and 4) a Manufacturing Site Move for 8-pin filters.
P020030/S009
2/16/12
Stelid II BFT/BJF/Stelix BR/Stelix II BRF Endocardial Pacing Leads ELA Medical, Inc. Plymouth, MN
55441
Clean room layout modifications of Saluggia, Italy plant.
P020036/S022
2/6/12
S.M.A.R.T. and S.M.A.R.T. CONTROL Nitinol Stent System Cordis Corporation
Miami Lakes, FL
33014
Use of new equipment for the UV bonding process.
P020047/S044
2/21/12
Multi-Link 8 Coronary Stent System Abbott Vascular, Inc.
Temecula, CA
92591
Modification of a marker alignment template; and a change to the in-process acceptance criteria for one balloon length size.
P030017/S126
2/17/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Changes to the nickel strip welding process at the battery terminals for the device.
P030017/S127
2/17/12
Precision Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Changes to the nickel strip welding process to the kovar tabs for the device.
P030017/S128
2/29/12
Precision Spinal Cord Stimulation (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Addition of clarifications to the existing visual inspection criteria for the feedthrough component of the Implantable Pulse Generator (IPG).
P030024/S018
2/23/12
VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc.
Rochester, NY
14626
Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P030026/S025
2/23/12
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator Ortho Clinical Diagnostics, Inc.
Rochester, NY
14626
Changing the timing of the tests in the QA release test from sequential to concurrent, described as the Single Test.
P030028/S003
2/3/12
Artisan-Verisyse Myopia Phakic IOL OPHTEC, USA, Inc.
Boca Raton, fL
33487
Change in the Poly-methyl methacrylate (PMMA) material.
P030035/S093
2/2/12
Anthem CRT-P Devices St. Jude Medical, CRMD
Sylmar, CA
91342
Alternate supplier for RF electronic assembly modules.
P030047/S023
2/6/12
PRECISE OTW, PRECISE RX and PRECISE PRO RX Nitinol Stent System Cordis Corporation
Miami Lakes, FL
33014
Use of new equipment for the UV bonding process.
P040002/S036
2/15/12
AFX Endovascular AAA System Endologix, Inc.
Irvine, CA
92618
Change to your ePTFE graft manufacturing process.
P040004/S008
2/3/12
ADVIA Centaur HBc Total Assay Siemens Healthcare Diagnostic
E. Walpole, MA
02032
Adding an in-process step to the preparation of the labeled antigen.
P040008/S002
2/8/12
VIDAS TOTAL PSA (TPSA) BioMèrieux, Inc.
Hazelwood, MO
63042
Add an alternate supplier of the critical component Solid Phase Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA products.
P040020/S039
2/16/12
AcrySof ReSTOR Intraocular Lenses Alcon Laboratories, Inc.
Forth Worth, TX
76134
Add a molding system.
P040037/S040
2/6/12
Gore Viabahn Endoprosthesis, Gore Viabahn Endoprosthesis with Heparin W. L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Software modifications to the stent winding machine and incorporation of a barcode scanner.
P040037/S041
2/6/12
Gore VIABAHN Endoprosthesis W.L. Gore & Associates, Inc.
Flagstaff, AZ
86001
Temperature change in the device loading process.
P040045/S031
2/9/12
VISTAKON (senoficon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL
32256
Use of a different clarifying filter for senofilcon A monomer mixing during manufacturing.
P040048/S016
2/10/12
Trilogy AB Acetabular System Zimmer, Inc.
Warsaw, IN
46580
Use of new labeling software.
P050046/S013
2/29/12
Acuity Steerable
Leads
Boston Scientific Corporation
St. Paul, MN
55112
Change to the bacterial endotoxin sampling plan.
P050047/S021
2/23/12
Juvèderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Review of the annual revalidation of the Juvèderm sterilization cycle, and the qualification of a new sterilizer.
P060008/S084
2/15/12
TAXUS Liberte Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Modification of water system monitoring.
P060027/S036
2/2/12
Paradym CRT-D Sorin CRM USA, Inc.
Plymouth, MN
55441
Additional oven, an updated cleaning process, and an update to the rework process.
P060027/S037
2/16/12
Paradym CRT, Situs OTW Leads ELA Medical, Inc. Plymouth, MN
55441
Clean room layout modifications of Saluggia, Italy plant.
P060037/S016
2/10/12
NexGen LPS-Flex/LPS-Mobile Bearing Knee Zimmer, Inc.
Warsaw, IN
46580
Use of new labeling software.
P080008/S001
2/8/12
VIDAS FREE PSA (FPSA) BioMèrieux, Inc.
Hazelwood, MO
63042
Add an alternate supplier of the critical component Solid Phase Receptacle (SPR-pm) for the VIDAS® Total PSA and Free PSA products.
P080010/S007
2/29/12
SENSAR 1-Piece Lens and TECNIS Multifocal Lens Abbott Medical Optics, Inc.
Santa Ana, CA
92705
Implement a software and hardware upgrade to the equipment used to measure optical properties of intra- ocular lenses.
P080011/S007
2/23/12
Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Change in the frequency of sanitization of the inspection trays used in the automated wet line inspection process.
P080011/S008
2/23/12
Biofinity (Comfilcon A) Soft Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Change in the storage conditions for lenses awaiting automated wet line inspection.
P080011/S010
2/29/12
Biofinity (Comfilcon A) Soft (Hydrophilic) Extended Wear Contact Lenses CooperVision, Inc.
Pleasanton, CA
94588
Installation of a duplicate autoclave.
P090013/S050
2/29/12
Revo MRI IPGs Medtronic, Inc.
Mounds View, MN
55112
Reduction in line testing sample size for a component.
P100010/S014
2/9/12
Arctic Front Cardiac CryoAblation Catheter Medtronic CryoCath LP
Pointe Claire, Quebec, Canada
H9R 5Z8
Raw material change to a component of the device.
P100021/S013
2/29/12
Endurant Stent Graft System Medtronic Vascular
Santa Rosa, CA
95403
Change to mandrel material.
P100023/S034
2/15/12
ION (TAXUS Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation
Maple Grove, MN
55311
Modification of water system monitoring.
P100029/S010
2/6/12
Trifecta Valve St. Jude Medical, Inc.
St. Paul, MN
55117
Changes to include: 1) An alternate electropolishing method; 2) semi-automation of stent rotation; and 3) change in fixture material.
P100041/S005
2/17/12
Edwards Sapien Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Use of a new cleanroom and changes to crimper molds.
P110019/S010
2/21/12
XIENCE Prime and XIENCE Prime LL Everolimus-Eluting Coronary Stent Systems Abbott Vascular, Inc.
Temecula, CA
92591
Modification of a marker alignment template; and a change to the in-process acceptance criteria for one balloon length size.
P110022/S003
2/27/12
Elecsys® Anti-HBc IgM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110022/S004
2/27/12
Elecsys® Anti-HBc IgM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110022/S005
2/27/12
Elecsys® Anti-HBc IgM on cobas e 601 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S003
2/27/12
Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S004
2/27/12
Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110025/S005
2/27/12
Elecsys® Anti-HBc IgM on MODULAR ANALYTICS E170 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S003
2/27/12
Elecsys® Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Manufacturing process change to increase the concentration of the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S004
2/27/12
Elecsys® Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to the in- process particle concentration determination method for the Intermediate Storage Form (ISF) bulk component common to all devices.
P110031/S005
2/27/12
Elecsys® Anti-HBc IgM on cobas e 411 Roche Diagnostics Corporation
Indianapolis, IN
46250
Change to increase production capacity for the Intermediate Storage Form (ISF) bulk component common to all devices.

Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 58

Summary of PMA Originals Under Review
Total Under Review: 73
Total Active: 29
Total On Hold: 44
Number Greater Than 180 Days: 2

Summary of PMA Supplements Under Review
Total Under Review: 642
Total Active: 477
Total On Hold: 165
Number Greater Than 180 Days: 7

Summary of All PMA Submissions Received
Originals: 1
Supplements: 92

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 58
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 187.4
FDA Time: 132.2 Days MFR Time: 55.2 Days