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PMA Final Decisions Rendered for June 2003 |
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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.
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
|
6/6/03 |
ThinPrep® Imaging System |
Cytyc Corporation Boxborough, MA 01719 |
Approval for the ThinPrep® Imaging System. The device is indicated for assisting in primary cervical cancer screening of ThinPrep® Pap Test™ slides for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions, and carcinoma as well as all other cytological criteria as defined by The 2001 Bethesda System: Terminology for Reporting Results of Cervical Cytology. |
|
6/11/03 |
FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter |
X Technologies, Inc. Tustin, CA 92870 |
Approval for the FX miniRAIL™ RX Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter. The device is indicated for balloon dilatation of the stenotic portion of a coronary artery, including in-stent restenosis, for the purpose of improving myocardial perfusion. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810044/S004 6/12/03 180-Day |
Sleep Sentry™ |
Diabetes Sentry Products Bellingham, WA 98225 |
Approval
for changes to the physical design and layout of the device, device labeling,
and manufacturing facilities and processes. The manufacturing sites are
located at Diabetes Sentry Products, Inc. (DSP), Bellingham Washington and Datrend Systems, Inc., Richmond,
BC
|
| P830055/S084 6/10/03 Real-Time |
LCS Total Knee System |
DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for two line extensions: the addition of PFC Sigma RP TC3 tibial inserts that are compatible with the MBT Revision tibial tray components, and adding a smaller (size 1.5) PFC Sigma RP tibial insert in both curved and stabilized versions. |
| P890064/S012 6/20/03 Special |
Digene Hybrid Capture 2 HPV DNA Test |
Digene Corporation Gaithersburg, MD 20878 |
Approval for modification of lot release testing for detection reagent 1 (DR1) component. |
| P910073/S042 6/24/03 Real-Time |
ENDOTAK RELIANCE® Steroid Eluting Endocardial Defibrillation Lead Models 0143/0153 |
Guidant Corporation St. Paul, MN 55112 |
Approval for 70-cm lead lengths for the ENDOTAK RELIANCE® Steroid Eluting Endocardial Defibrillation Lead (Models 0143 and 0153). |
| P920047/S019 6/19/03 180-Day |
EPT-1000 Cardiac Ablation System |
Boston Scientific EP Technologies San Jose, CA 95134 |
Approval for a new manufacturing facility located at Plexus EA Seattle, Bothell, Washington. |
| P930014/S009 6/24/03 180-Day |
AcrySof® NATURAL Single-Piece Posterior Chamber Intraocular Lens (Model SB30AL) |
Alcon Research Ltd. Fort Worth, TX 76134 |
Approval for the AcrySof® NATURAL Single Piece Intraocular Lens (Model SB30AL). The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults when extracapsular cataract extraction or phacoemulsifica-tion are performed. These lenses are intended for placement in the capsular bag. |
| P950020/S008 6/4/03 Real-Time |
Cutting Balloon Ultra2 |
Boston Scientific – Interventional Technologies San Diego, CA 92123 |
Approval for a two year shelf life for both the Over-the-Wire (OTW) and Monorail (MR) devices. |
| P960013/S013 6/13/03 Real-Time |
Tendril® SDX Permanent Pacemaker Leads, Models 1688T/TC |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for addition of a fluoroscopic marker in the helix tip, and is indicated for permanent sensing and pacing in either the atrium or the ventricle, in combination with a compatible pulse generator. |
| P960040/S033 6/25/03 Real-Time |
VENTAK® PRIZM™ AVT™ AICD™, Model 2849, Programmer Software Version 2.5 |
Guidant Corporation St. Paul, MN 55112 |
Approval for the VENTAK® PRIZM™ AVT™ AICD™, Model 2849, Programmer Software Version 2.5 |
| P960052/S006 6/13/03 Real-Time |
Dermabond® Topical Skin Adhesive |
Closure Medical Corporation Raleigh, NC 27616 |
Approval for two changes to the labeling: 1) change the instructions for use to state that two layers of adhesive should be applied instead of three layers and 2) the addition of language stating that the device can act as a barrier to microbial penetration when intact. |
| P960058/S031 6/6/03 Real-Time |
CII Bionic Car System, HiRes™ Auria™ Processor and Accessories |
Advanced Bionics Corporation Sylmar, CA 91342 |
Approval for changes to the following parts of the behind-the-ear (BTE) sound processor: 1) the toggle switch, 2) the BTE battery, 3) the accessories available with the current BTE, 4) the new accessory items, 5) the Auria™ Headpiece, and 6) the ESD warning in the Package Insert. |
| D970012/S014 6/17/03 180-Day |
AMS 700™ Series Inflatable Penile Prosthesis Product Line |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval for modifications to the physician and patient labeling to summarize the results of the postapproval study. |
| P970015/S021 6/24/03 180-Day |
Inter Fix
Threaded Fusion Device, Inter Fix RP |
Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for an additional manufacturing facility to perform packaging for terminal sterilization. The facility is located at Medtronic Sofamor Danek, Warsaw, Indiana. Also, approval for an additional sterilization facility located at IBA SteriGenics, Westerville, Ohio and an additional testing facility located at NaMSA, Northwood, Ohio. |
| P980035/S029 6/6/03 Real-Time |
Medtronic Sigma Pacing System and Medtronic 350 Series Pacing System |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for modifications to the connector in the Sigma and 350 Series pacemakers to improve yield and manufacturability. |
| P990020/S012 6/19/03 135-Day |
The AneuRx™ Stent System |
Medtronic AVE Santa Rosa, CA 95403 |
Approval for the modification to the manufacturing process to allow the AneuRx™ Stent Graft to be unloaded and reloaded into a new PMA-approved delivery system. |
| P990037/S019 6/13/03 Real-Time |
Diagnostic Duett Sealing Device (Model 2200), Diagnostic Duett Pro Sealing Device (Model 2210), and D-Stat Flowable Hemostat (Model 4000) |
Vascular Solutions, Inc. Minneapolis, MN 55369 |
Approval for a shelf-life extension of the TRIS diluent component, for the devices listed above, from the approved 24 months to 36 months. |
| P990039/S001 6/19/03 180-Day |
QUS-2 Calcaneal Ultrasonometer |
Quidel Corporation Santa Clara, CA 95051 |
Approval for a new manufacturing facility located at Plexus EA, Seattle, Bothell, Washington. |
| P990041/S003 6/11/03 180-Day |
ETI-AB-EBK PLUS |
DiaSorin Baldwin, MD 21013 |
Approval for the revised package insert. |
| P990042/S006 6/30/03 180-Day |
ETI-AB-AUK PLUS |
DiaSorin Baldwin, MD 21013 |
Approval for inclusion of post-approval study results in the package insert. |
| P990043/S004 6/26/03 180-Day |
ETI-EBK PLUS |
DiaSorin Baldwin, MD 21013 |
Approval for the revised package insert. |
| P990044/S003 6/26/03 180-Day |
ETI-CORE-IGMK PLUS |
DiaSorin Baldwin, MD 21013 |
Approval for the revised package insert. |
| P990045/S004 6/26/03 180-Day |
ETI-AB-COREK PLUS |
DiaSorin Baldwin, MD 21013 |
Approval for the revised package insert. |
| P000018/S028 6/25/03 180-Day |
Beta-Cath™ 3.5F System – 60mm |
Novoste Corporation Norcross, GA 30093 |
Approval for the 60 mm Beta-Cath™ 3.5F System. The device, as modified, is indicated to deliver beta radiation to the site of successful percutaneous coronary intervention (PCI) for the treatment of in-stent restenosis in native coronary arteries with discrete lesions (treatable with a 20 mm balloon for the 30 mm and 40 mm Systems and injury areas up to 40 mm for the 60 mm System) in a reference vessel diameter ranging from 2.7 mm to 4.0 mm. |
| P000025/S007 6/5/03 180-Day |
MED-EL COMBI 40+ Cochlear Implant System with C40+, C40+S, or C40+GB Implants, and CIS PRO+/TEMPO+ Speech Processors |
MED-EL Corporation Durham, NC 27713 |
Approval of an Indication for Use allowing the use of Magnetic Resonance Imaging (MRI) at 0.2 Tesla for patients implanted with COMBI 40+ Cochlear Implants (C40+, C40+S and C40+GB Electrode Arrays). |
| P000041/S001 6/30/03 180-Day |
RapidScreen RS-2000D |
Deus Technologies Rockville, MD 20850 |
Approval for the addition of the ability of the RapidScreen RS-2000D to process digital images in addition to film/screen images. The device, as modified, will be marketed under the trade name RapidScreen RS-2000D and is indicated for: The RS-2000D is a computer-aided detection (CAD) system intended to identify and mark regions of interest (ROIs) on digital or digitalized frontal chest radiographs. It identifies features associated with solitary pulmonary nodules from 9 to 30 mm in size, which could represent early-stage lung cancer. The device is intended for the use as an aid only after the physician has performed an initial interpretation of the radiograph. |
| P000043/S006 6/24/03 Real-Time |
TMx-2000™ BPH Thermotherapy System (Rx-200 Treatment Catheter) |
TherMatrx™ Inc. Northbrook, IL 60062 |
Approval to extend the shelf life of the Rx-200 Treatment Catheter (a component of the TMx-2000™ BPH Thermotherapy System) to three (3) years. |
| P000052/S016 6/27/03 180-Day |
Galileo Intravascular Radiotherapy System |
Guidant Corporation Houston, TX 77054 |
Approval for an alternate manufacturing facility for the Source Blank Subassembly. The facility is located at Guidant Corporation, Houston, Texas. |
| P000053/S001 6/16/03 Real-Time |
AMS Sphincter 800™ Urinary Prosthesis |
American Medical Systems, Inc. Minnetonka, MN 55343 |
Approval of the “Quick Connect” sutureless window 3-way connector, an accessory to the AMS Sphincter 800™ Urinary Prosthesis. |
| P000058/S003 6/24/03 180-Day |
Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion Device |
Medtronic Sofamor Danek Memphis, TN 38132 |
Approval for an alternate manufacturing facility for assembling and packaging the parts of the Infuse Bone Graft component of the device. The facility is located at Medtronic Sofamor Danek USA, Inc., Memphis, Tennesee. |
| P010012/S008 6/13/03 180-Day |
CONTAK® RENEWAL™ 3 CRT-D Models H170/H175, CONTAK® RENEWAL™ 3 HE CRT-D Models H177/H179, and Model 2845 Version 2.2 Software |
Guidant Corporation St. Paul, MN 55112 |
Approval for the CONTAK® RENEWAL™ 3 CRT-D Models H170/H175, CONTAK® RENEWAL™ 3 HE CRT-D Models H177/H179, and Model 2845 Version 2.2 Software. The CONTAK® RENEWAL™ 3 System is indicated for patients who are at high risk of sudden cardiac death due to ventricular arrhythmias and who have moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF £ 35%) and QRS duration ³ 120 ms and remain symptomatic despite stable, optimal heart failure drug therapy. Patient populations at high risk of sudden cardiac death due to ventricular arrhythmias include, but are not limited to, those with: 1) Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to a ventricular tachyarrhythmia. 2) Recurrent, poorly tolerated sustained ventricular tachycardia (VT). NOTE: The clinical outcome of hemodynamically stable, sustained-VT patients is not fully known. Safety and effectiveness studies have not been conducted. 3) Prior myocardial infarction, left ventricular ejection fraction of £35%, and a documented episode of nonsustained VT, with an inducible ventricular tachy-arrhythmia. Patients suppressible with IV procainamide or an equivalent antiarrhythmic (drug) have not been studied. |
| P010012/S010 6/13/03 Real-Time |
EASYTRAK® Lead Models IS-1 4535/4536/4537/4538 Coronary Venous Steroid-Eluting Single-Electrode Pace/Sense Lead |
Guidant Corporation St. Paul, MN 55112 |
Approval for change from a LV-1 lead connector to an IS-1 lead connector design. The device, as modified, will be marketed under the trade name EASYTRAK IS-1 Lead, and is indicated for chronic left ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible cardiac resynchronization therapy (CRT) device. |
| P010012/S013 6/9/03 Real-Time |
FINISHING WIRE® Universal, Models 6001-6007 |
Guidant Corporation St. Paul, MN 55112 |
Approval for modifications to the Finishing Wire cap section of the commercially available FINISHING WIRE® Universal which will allow it to be compatible with the IS-1 terminal pin as well as the LV-1 terminal pin of the EASYTRAK Leads. The device, as modified, will be marketed under the trade name FINISHING WIRE® Universal, Models 6001-6007 and is indicated for use with Guidant coronary vendus leads. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE OF APPROVAL | DEVICE TRADE NAME | COMPANY NAME, CITY, STATE AND ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P860047/S014 6/6/03 |
Ocucoat® (2% Hydroxypropyl-methylcellulose Solution) |
Bausch & Lomb San Dimas, CA 91773 |
Change in the frequency of the bioburden testing for Ocucoat. |
| P980018/S002 6/11/03 |
DakoCytomation Hercep Test™ |
DakoCytomation California, Inc. Carpinteria, CA 93013 |
Change in the manufacturing method for the conjugation of the two proteins to the activated dextran to one step followed by only one purification step. |
| P990026/S017 6/17/03 |
GlucoWatch® Automatic Glucose Biographer |
Cygnus, Inc. Redwood City, CA 94063 |
Change to an equivalent in-house supplier of the raw material Platinum/Carbon (Pt/C) composite electrode ink for the manufacture of the GlucoWatch® Biographer AutoSensor. |
| P000018/S033 6/11/03 |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, GA 30093 |
Converting demonstrator devices to commercially available devices by adding an antimicrobial flush to the manufacturing process. |
| P000018/S034 6/25/03 |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, GA 30093 |
Change of additional programming and use of a reworked printed circuit board assembly. |
| P010018/S002 6/9/03 |
ViewPoint™ CK System |
Refractec®, Inc. Irvine, CA 92618 |
Alternate test method for evaluation of the radiofrequency output of the RCS-300 console during final device testing. |
| P010050/S003 6/11/03 |
IMMULITE®, IMMULITE® 1000 and IMMULITE® 2000 HBsAg Kits |
Diagnostic Products Corporation Los Angeles, CA 90045 |
Additions to the manufacturing process and provide additional assurance of purity, identity, strength and reliability for the device. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 31
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 36
Total On Hold: 43
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 240
Total Active: 126
Total On Hold: 114
Number Greater Than 180 Days: 4
Summary of All PMA Submissions Received
Originals: 7
Supplements: 64
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 31
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 111.1
FDA Time: 78.2 Days MFR Time: 32.9 Days
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