Medical Devices
August 2005 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for August 2005. 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. Information about the PDF Reader is available.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
8/3/05 |
SelectSecure™ Lead Model 3830 |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the SelectSecure Lead Model 3830. The Model 3830 lead has applications where implantable atrial or ventricular, single-chamber or dual-chamber pacing systems are indicated. The model 3830 lead is intended for pacing and sensing in the atrium or ventricle. |
|
8/5/05 |
SJM Biocor™ Valve and the SJM Biocor™ Supra Valve |
St. Jude Medical, Inc. St. Paul, MN 55117 |
Approval for the SJM Biocor Valve and the SJM Biocor Supra Valve. |
|
8/10/05 |
Orbasone Pain Relief System |
Orthometrix, Inc. White Plaines, NY 10604 |
Approval for the Orbasone Pain Relief System. The device is indicated for extracorporeal shock wave therapy for the treatment of chronic proximal plantar fasciitis in patients 18 years of age or older that have failed to respond to conservative therapy. Chronic proximal plantar fasciitis is defined as heel pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for six months or more. |
|
8/17/05 |
Matrix VSG™ System, model MX-1000 |
AccessClosure, Inc. Mountain View, CA 94043 |
Approval for the Matrix VSG™ System, model MX-100. The device is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F, or 7F procedural sheath. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|
P850020/S020 8/17/05 180-Day |
PROSORBA® Protein A Immunoadsorption Column | Fresenius Medical Care North America | Approval for Ethylene Oxide (EO) sterilization site located at Steris Isomedix Services, Inc., Waukegan, Illinois. |
|
P850020/S021 8/25/05 Special |
PROSORBA® Column | Fresenius Medical Care North America | Approval for a labeling change to include information on the use of the ART Hemoadsorption System in conjunction with the PROSORBA Column. |
|
P860003/S043 8/19/05 Real-Time |
UVAR® XTS™ Photopheresis System |
Therakos, Inc. Exton, PA 19341 |
Approval for a new centrifuge leak sensor. |
|
P910077/S050 8/15/05 180-Day |
Model 3120 ZOOM® Latitude™ Programmer/ Recorder/Monitor, Model 3122 Antenna Accessory, and CONSULT Programmer Software Application Model 2845 Version 4.12 |
Guidant Corp. St. Paul, MN 55112 |
Approval for the addition of a second internal antenna to the Model 3120 ZOOM® Latitude™ Programmer/Recorder/Monitor, a labeling update for the Model 3122 Antenna Accessory, CONSULT Programmer Software Application Model 2845 Version 4.12, and minor manufacturing process changes. |
|
8/30/05 Panel |
STAR S4 IR™ Excimer Laser System with Variable Spot Scanning (VSS™) and WaveScan WaveFront ® System |
VISX, Inc. Santa Clara, CA 95051 |
Approval for the STAR S4 IR™ Excimer Laser System with VSS™ and WaveScan WaveFront® System. The device uses a 6.0 mm optical zone, an 8.0 mm treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of myopia and myopic astigmatism from -6.0 to -11.00 D MRSE, with cylinder between 0.00 and -3.00 D; 2) in patients 21 years of age or older, and 3) in patients with documented evidence of a change in manifest refraction of no more than 1.00 D (in both cylinder and sphere components) for at least one year prior to the date of pre-operative examination. |
|
P950039/S012 8/5/05 180-Day |
ThinPrep 2000 System |
Cytyc Corp. Marlborough, MA 01752 |
Approval for an addition to the current labeling, with regard to the evaluation of glandular abnormalities using the ThinPrep 2000 System. |
|
P960043/S057 8/11/05 Special |
Perclose ProGlide™ 6 French Suture-Mediated Closure (SMC) System |
Abbott Laboratories Redwood City, CA 94063 |
Approval for revised instructions for use. |
|
P970004/S029 8/4/05 180-Day |
Medtronic Interstim® Sacral Nerve Stimulation (SNS)™ System |
Medtronic, Inc. Shoreview, MN 55126 |
Approval for: 1) shipment of patient cable (Model 041831) after manufacturing to Medtronic Neurological Division, Sullivan Lake Facility, Minneapolis, Minnesota, for cleaning, packaging and ethylene oxide sterilization, 2) extension of the current 2-year shelf life of the patient cable to 4 years using ethylene oxide sterilization and 3) labeling changes that involve combining the separate manuals for the Model 3065U kit and the Model 3057 Lead into one manual and to replace the combined manual for Models 041831, 041829, 041828, 041827 and 041826 with separate single sheet IFUs (information for use). |
|
P980016/S053 8/19/05 Real-Time |
RAMware (Baseline 15 with Inc5 RAMware) update to the Medtronic EnTrust 30J/35J ICD Systems |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for the RAMware (Baseline 15 with Inc5 RAMware) update to the Medtronic EnTrust 30J/35J ICD Systems for the following Models: Medtronic® EnTrust Model D153ATG; Medtronic® EnTrust Model D153DRG; Medtronic® EnTrust Model D153VRC; Medtronic® EnTrust Model D154ATG; Medtronic® EnTrust Model D154DRG; and Medtronic® EnTrust Model D154VRC. |
|
P980022/S012 8/24/05 180-Day |
Guardian RT |
Medtronic MiniMed Northridge, CA 91325 |
Approval for modifications to the sensor to include the use of human serum albumin in place of bovine serum albumin as a stabilizer and a change to the manufacturing process removing the outer hydrophilic membrane. |
|
P000009/S016 8/11/05 Real-Time |
Lumos VR-T and Lumos DR-T Implantable Cardioverter Defibrillators with 502.U ICS Programmer Software, A-K00.4.U EPR/ TMS Programmer Software, and Home Monitoring Version 1.7.1 |
Biotronik, Inc. Lake Oswego, OR 97035 |
Approval to implement intracardiac electrogram (IEGM) snapshots of tachycardia events into Home Monitoring transmissions. In order to accomplish this, you have requested the approval of the Lumos family of ICDs programmer software upgrades, and an upgrade to the currently marketed Home Monitoring Service Center. |
|
P000029/S012 8/2/05 180-Day |
Deflux® Injectable Gel |
Q-Med Scandinavia, Inc. Princeton, NJ 08540 |
Approval for modification of the post approval study protocol to: 1) replace the 1- and 5-year voiding cystourethrogram measurements with clinical assessments of “febrile UTI;”and 2) decrease the total sample size from 200 to 149 patients. |
|
P000046/S011 8/3/05 Special |
Shellgel™ Sodium Hyaluronate |
Anika Therapeutics, Inc. Woburn, MA 01801 |
Approval for the change in labeling to include cannula assembly instructions and four addition languages. |
|
P000054/S003 8/22/05 135-Day |
INFUSE® Bone Graft |
Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the addition of a raw material supplier. |
|
P000058/S014 8/22/05 135-Day |
INFUSE® Bone Graft/LT CAGE® Lumbar Tapered Fusion Device |
Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for the addition of a raw material supplier. |
|
P010012/S044 8/15/05 180-Day |
CONTAK RENEWAL 3 RF CRT-D Models H210/H215/H250/ H255; CONTAK RENEWAL 3 RF CRT-D Models H217/H219/ H257/259; CONTAK RENEWAL 3 RF HE Pulse Generator Software Version 1.2; and CONSULT programmer Software Application Model 2845 Version 4.12 |
Guidant Corporation St. Paul, MN 55112 |
Approval for CONTAK RENEWAL 3 RF Pulse Generator Software Version 1.2 and CONSULT Programmer Software Application Model 2845 Version 4.12. Also approval to replace the existing Polyimide tubing that provides insulation in the pulse generator header assembly with Polyetheretherke-tone (PEEK) tubing. |
|
P010012/S056 8/16/05 Real-Time |
CONTAK RENEWAL Model H135; CONTAK RENEWAL 3 Models H170, H173 & H175; CONTAK RENEWAL 3 HE Models H177 & H179; CONTAK RENEWAL 3 RF Models H210, H215, H250 & H255; CONTAK RENEWAL 3 RF HE Models H217, H219, H257, & H259; CONSULT Programmer Software Application Model 2845 Version 4.12 |
Guidant Corporation St. Paul, MN 55112 |
Approval for 1) An alternate magnetic reed switch manufactured by Hermetic and an associated change to the equipment used in the rework of this component (only in CONTAK RENEWAL 3 RF Models H210, H215, H250 & H255 and CONTAK RENEWAL 3 RF HE Models H217, H219, H257, & H259); and 2) CONSULT Programmer Software Application Model 2845 Version 4.12. |
|
P010015/S013 8/12/05 180-Day |
InSync Registry |
Medtronic, Inc. Minneapolis, MN |
Approval to incorporate CRT devices with defibrillator capabilities (CRT-D into the InSync Registry. |
|
P010021/S006 8/11/05 135-Day |
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator |
Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Approval for extension of shelf-life and bioburden for a manufacturing component. |
|
P030017/S008 8/18/05 180-Day |
PRECISION™ Spinal Cord Stimulation (SCS) System |
Advanced Bionics Sylmar, CA 91342 |
Approval for Artisan 2 X 8 Paddle Lead, Model SC-8116-xx. |
|
P040043/S006 8/31/05 180-Day |
GORE TAG Thoracic Endoprosthesis |
W.L. Gore and Associates Flagstaff, AZ 86001 |
Approval of the post-approval study protocol. |
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 |
|
P880081/S031 8/4/05 |
AMO Silicone Monofocal and Multifocal Intraocular Lens |
Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the outer IOL box. |
|
P880086/S105 8/25/05 |
Affinity, Identity, Integrity, and Frontier family of Devices |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Addition of a spot laser weld to the resistance weld that bonds the feedthrough wire to the connector wire. |
|
P880086/S106 8/25/05 |
Affinity, Identity, Integrity, and Frontier family of Devices |
St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Change of the manual epoxy dispensing method to a semi-automated robot controlled epoxy dispensing system. |
|
P910073/S052 8/3/05 |
RELIANCE ACTIVE FIX and Passive FIX Steroid Eluting Endocardial Defibrillation Lead |
Guidant Corporation St. Paul, MN 55112 |
Addition of a sight hole in one side of the electrode base. |
|
P910073/S053 8/31/05 |
Reliance Leads |
Guidant Corporation St. Paul, MN 55112 |
Addition of helix inspection criteria to the manufacturing instructions. |
|
P930038/S045 8/31/05 |
Angio-Seal |
St. Jude Medical Daig Division, Inc. Minnetonka, MN 55345 |
Change to use the semi-automated Back Half Machine System. |
|
P960006/S016 8/4/05 |
FLEXTEND Family of Pacing Leads |
Guidant Corporation St. Paul, MN 55112 |
Addition of primer to the inner surface of the electrode ring of the FLEXTEND leads to increase adhesion of the electrode ring to the molded neck. |
|
P960006/S017 8/31/05 |
Flextend Leads |
Guidant Corporation St. Paul, MN 55112 |
Addition of helix inspection criteria to the manufacturing instructions. |
|
P960028/S014 8/4/05 |
AMO Silicone Monofocal and Multifocal Intraocular Lens |
Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change in the outer IOL box. |
|
P990045/S008 8/29/05 |
ETI-AB-COREK PLUS |
DiaSorin S.p.A Saluggia, Italy 13040 |
Change in determination of specific attributes of quality control for a raw reagent. |
|
P000037/S007 8/25/05 |
On-X® Prosthetic Heart Valve |
MCRI, Inc. Austin, TX 78754 |
Change in manufacturing for the On-X valve that entails a family of changes to CMM software and related procedures. |
|
P000044/S007 8/8/05 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit |
Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in raw reagent supplier and material specifications. |
|
P010012/S054 8/4/05 |
CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator (CRT-D), Models H135, H170, H175, H177, and H179 |
Guidant Corporation St. Paul, MN 55112 |
Change in test software for the CONTAK RENEWAL CRT-D Devices per routine procedures. |
|
P010012/S059 8/25/05 |
Contak Renewal Models H170, H175, H177, H179, H210, H215, H217, H219, H250, H255, H257, H259 |
Guidant Corporation St. Paul, MN 55112 |
Addition of a stiffener fixture and flux dispense to the rework process. |
|
P030025/S022 8/31/05 |
TAXUS™ Express2™ Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of a “Pesticide Residue Test”from the incoming raw material specification for toluene used in the stent coating process. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 21
Summary of PMA Originals Under Review
Total Under Review: 86
Total Active: 32
Total On Hold: 54
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 329
Total Active: 177
Total On Hold: 152
Number Greater Than 180 Days: 6
Summary of All PMA Submissions Received
Originals: 5
Supplements: 107
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 21
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 144.6
FDA Time: 109.3 Days
MFR Time: 35.3 Days