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PMA Final Decisions Rendered for January 2003 |
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Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
|
1/24/03 |
Dimension® FPSA Flex® Reagent Cartridge and Dimension® T/F PSA Calibrator for Dimension® RxL and Xpand™ Systems |
Dade Behring, Inc. Newark, DE 19714 |
Approval for the Dimension FPSA Flex Reagent Cartridge and Dimension T/F PSA Calibrator for Dimension RxL and Xpand Systems. The Dimension FPSA Flex Reagent Cartridge is indicated for: The FPSA method for the Dimension clinical chemistry system with the heterogenous immunoassay module is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (FPSA) in human serum. Measurement of FPSA are used in conjunction with total PSA (TPSA) method on Dimension system to calculate FPSA to TPSA ratio expressed as a percent FPSA. The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 10.0 ng/mL [ug/L] and digital rectal examination (DRE) findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer. The Dimension T/F PSA Calibrator is indicated for: The T/F PSA Calibrator is an in vitro diagnostic product intended to be used to calibrate the Total (TPSA) and Free (FPSA) Prostate Specific Antigen methods for the Dimension clinical chemistry system with the heterogeneous immunoassay module. This product was designed to meet the needs of users to assure accurate results over the assay range of these methods. |
|
1/3/03 |
Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen Saturation Monitoring |
Philips Medical Systems, Inc. Andover, MA 01810 |
Approval for the Series 50 XMO (Model M1350C) Fetal/Maternal Monitor System with Integrated Fetal Oxygen Saturation Monitoring, M1365A Fetal SpO2 Patient Module, and the Nellcor OxiFirst™ FS14 Sensor. This device is intended for continuous monitoring of intrapartum fetal oxygen saturation (FSpO2) and the FSpO2 parameter is indicated as an adjunct to fetal heart rate (FHR) monitoring in the presence of a nonreassuring fetal heart rate pattern. It should only be used after amniotic membranes have ruptured and on a singleton fetus in vertex presentation with a gestational age greater than or equal to 36 weeks. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N18-033/S038 1/8/03 Real-Time |
ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker |
VISTAKON, Division of Johnson and Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Approval for an alternative binding polymer to the ACUVUE® 2 COLOURS™ Brand (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker. |
| P790027/S068 1/27/03 180-Day |
PMMA Posterior Chamber Intraocular Lenses |
Bausch & Lomb, Inc. San Dimas, CA 91773 |
Approval for a facility change to produce the violet compression molded (BCM) blank PMMA material at Bausch & Lomb, Inc., Wilmington, Massachusetts. |
| P830045/S083 1/22/03 Real-Time |
Application Software Model 3307 (Version 4.1a) |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model 3307 (Version 4.1a) programmer software for SJM Models 3500/3510 programmer. |
| P850048/S018 1/9/03 Real-Time |
Access Hybritech PSA on the SYNCHRON LXi 725 System |
Beckman Coulter, Inc. Brea, CA 92821 |
Approval to add the Access Hybritech PSA Assay to the SYNCHRON LXi 725 System. |
| P860019/S191 1/27/03 180-Day |
Boston Scientific Maverick™ 2 PTCA Catheter |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Approval for an alternate sterilization facility located at Cosmed Group, Inc., Coventry, Rhode Island. |
| P880086/S090 1/22/03 Real-Time |
AV Plus DX, Model 1368 |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for extending the shelf life of St. Jude Medical steroid-eluting bradycardia leads. |
| P880086/S091 1/22/03 Real-Time |
Application Software Model 3307 (Version 4.1a) |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model 3307 (Version 4.1a) programmer software for SJM Models 3500/3510 programmer. |
| P900061/S054 1/6/03 180-Day |
Medtronic Model 5719 Active Can® Emulator (ACE) Product |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for an alternate manufacturing and packaging facility located at Medtronic Arizona Device Manufacturing, Tempe, Arizona. |
| P900070/S028 1/22/03 Real-Time |
Application Software Model 3307 (Version 4.1a) |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model 3307 (Version 4.1a) programmer software for SJM Models 3500/3510 programmer. |
| P910023/S063 1/22/03 Real-Time |
Application Software Model 3307 (Version 4.1a) |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for Model 3307 (Version 4.1a) programmer software for SJM Models 3500/3510 programmer. |
| P930029/S019 1/8/03 Special |
Medtronic Enhancer Ablation Catheters |
Medtronic, Inc. Minneapolis, MN 55432 |
Approval for a manufacturing process change to add an additional quality control inspection. |
| P950022/S015 1/22/03 Real-Time |
Riata Series Defibrillation Lead System: RVL-ADX Model 1559, Riata Models 1570, 1571, 1580, and 1582 |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for extending the shelf life of St. Jude Medical steroid-eluting and tachycardia leads. |
| P960013/S012 1/22/03 Real-Time |
Tendril DX, Models 1388 T/K & Tendril SDX, Models 1488 T/K |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for extending the shelf life of St. Jude Medical steroid-eluting bradycardia leads. |
| P960030/S009 1/22/03 Real-Time |
Passive Plus DX, Models 1336T, 1342T, 1343K, 1345K, 1346T |
St. Jude Medical, Inc. Sylmar, CA 91342 |
Approval for extending the shelf life of St. Jude Medical steroid-eluting bradycardia leads. |
| P970004/S023 1/23/03 180-Day |
Medtronic® Interstim® Therapy for Urinary Control |
Medtronic Gastroenterology/ Urology Shoreview, MN 55126 |
Approval for the Model 8870 Interstim® Application Software to operating on the Model 8840 Clinician programmer, use of Enhanced Stimulation Desktop software, an expanded memory card storage, and updated labeling. These changes are used with the Medtronic® Interstim® Therapy for Urinary Control, which is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments. |
| P970038/S006 1/9/03 Real-Time |
Access Hybritech Free PSA on the SYNCHRON LXi 725 System |
Bechman Coulter, Inc. Brea, CA 92821 |
Approval to add the Access Hybritech Free PSA Assay to the SYNCHRON LXi 725 System. |
| P970042/S004 1/28/03 180-Day |
Medstone STS Lithotripter for the Treatment of Symptomatic, Solitary, Radiolucent, Non-Calcified Gallstones |
Medstone International, Inc. Aliso Viejo, CA 92656 |
Approval for 1) a change in the inclusion age limit for the post-approval study from 18-70 to 18 and over; 2) a change in the post approval study’s monitoring from RSI to Medstone; and 3) a change in the post-approval study’s Medical Monitor from RSI to Michael Albert, M.D. |
| P970054/S001 1/9/03 Special |
Biotrin Parvovirus B19 IgG Enzyme Immunoassay |
Biotrin International Dublin, Ireland |
Approval for adding a quality assurance inspection step. |
| P970055/S001 1/9/03 Special |
Biotrin Parvovirus B19 IgM Enzyme Immunoassay |
Biotrin International Dublin, Ireland |
Approval for adding a quality assurance inspection step. |
| P980012/S003 1/10/03 180-Day |
Novacor N100PC LVAS with optional ePTFE Inflow Conduit |
World Heart, Inc. Oakland, CA 94621 |
Approval for optional use of the re-designed ePTFE Inflow Conduit with the Novacor N100PC LVAS device system. |
| P980037/S006 1/14/03 Special |
AngioJet® Rheolytic™ Thrombectomy System |
Possis Medical, Inc. Minneapolis, MN 55433 |
Approval for modification to the manufacturing procedures for mounting of the hardware to the Drive Unit Control Board (i.e., implementation of a minimum torque requirement). |
| P980041/S003 1/29/03 Real-Time |
Access AFP Reagents on the UniCel™ Dxl 800 ACCESS Immunoassay System |
Beckman Coulter, Inc. Chaska, MN 55318 |
Approval for expanding the use of Access AFP Reagents on the UniCel™ Dxl 800 ACCESS Immunoassay System. The device, as modified, will be marketed under the trade name ACCESS AFP Immunoassay System and is indicated for the quantitative determinations of alpha-fetoprotein (AFP) in: 1) Human serum, as an aid in the management of patients with non-seminomatous testicular cancer. 2) Maternal serum and amniotic fluid at 15 to 20 weeks gestation, to aid in the detection of fetal open neural tube defects (ONTD). Test results, when used in conjunction with ultrasonography, are safe and effective aids in the detection of fetal ONTD. The assay is intended for use in conjunction with other diagnostic tools such as ultrasound and amiography. |
| P980052/S002 1/14/03 180-Day |
TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis |
TMJ Concepts Ventura, CA 93003 |
Approval for the addition of the sterile Patient-Fitted TMJ Reconstruction Prosthesis to be sterilized at TMJ Concepts, Ventura, California. |
| P990017/S037 1/2/03 180-Day |
ANCURE® ENDOGRAFT® System |
Guidant Corporation Menlo Park, CA 94025 |
Approval for an alternate manufacturing facility for the folded balloon subassembly located at Guidant Corporation, Temecula, California. |
| P990019/S002 1/9/03 180-Day |
BLU-U® |
DUSA Pharmaceuticals, Inc. Wilmington, MA 01887 |
Approval for extension of the calibration interval from the currently approved 500 cycles (with a 50 cycle buffer) to 1600 cycles (with a 50 cycle buffer). |
| P990037/S012 1/30/03 Real-Time |
Duett™ Pro sealing Device and the Diagnostic Duett™ Pro Sealing Device |
Vascular Solutions, Inc. Minneapolis, MN 55441 |
Approval for a design change to the Duett™ Pro Sealing Device and the Diagnostic Duett™ Pro Sealing Device. Specifically, 1) removal of the silicone gasket from the pressure relief valve design; 2) removal of a luer lock thread/attachment which was used to connect the catheter to the pressure relief valve and replace with an adhesive bond; 3) removal of the cap cover and threads from the relief valve, and 4) shortening of the length and height of the relief valve. |
| P990053/S006 1/7/03 180-Day |
OxiFirst Fetal Oxygen Saturation Monitoring System |
Nellcor Puritan Bennett, Tyco Healthcare Group LP Pleasanton, CA 94588 |
Approval for an alternate manufacturing site for the N-400 Fetal Pulse Oximeter. The manufacturing site is located at Nellcor Puritan Bennett Ireland, Galway, Ireland. |
| P000006/S002 1/14/03 180-Day |
Mentor Titan Inflatable Penile Prosthesis |
Mentor Corporation Santa Barbara, CA 93111 |
Approval for reprocessing final, sterilized Alpha I Inflatable Penile Prostheses to incorporate the hydrophilic coating that was previously approved for use on newly manufactured prostheses in supplement 1. The device, as modified, will be marketed under the trade name Mentor Titan Inflatable Penile Prosthesis and is indicated for male patients suffering from erectile dysfunction (impotence) who are considered candidates for implantation of a penile prosthesis. |
| P000008/S005 1/8/03 180-Day |
BioEnterics LAP-BAND Adjustable Gastric Banding System |
Inamed Corporation Santa Barbara, CA 93111 |
Approval for a manufacturing facility located at Inamed Corporation, Santa Barbara, California. |
| P000018/S025 1/6/03 180-Day |
Novoste™ Beta-Cath™ System |
Novoste Corporation Norcross, GA 30093 |
Approval for modifications to the design specification and manufacturing process for the β-Rail™ 3.5F Delivery Catheter (with 30 and 40 mm Indicator Source Train). |
| P000052/S013 1/21/03 135-Day |
GALILEO® III Intravascular Radiotherapy System |
Guidant Corporation Houston, TX 77054 |
Approval for an automated process for the tip forming operation of the GALILEO® III Centering Catheter. |
| P010002/S003 1/31/03 Special |
Indermil™ Tissue Adhesive |
U.S. Surgical Norwalk, CT 06856 |
Approval for the addition of a patient instruction sheet to the approved labeling. |
| P010012/S003 1/22/03 180-Day |
EASYTRAK® Lead Models 4510, 4511, 4512 and 4513 Coronary Venous Steroid Eluting Single-Electrode Pace/Sense Leads |
Guidant Corporation St. Paul, MN 55112 |
Approval for adding a polyurethane sleeve over the silicone insulation in the terminal connector area and minor changes to improve lead manufacturability. |
| P010013/S004 1/16/03 Real-Time |
NovaSure™ Impedance Controlled Endometrial Ablation System |
Novacept, Inc. Palo Alto, CA 94303 |
Approval for a manufacturing and material change to the cervical collar component of the Disposable Device. |
| P010041/S001 1/17/03 180-Day |
Carpentier-Edwards S.A.V. Bioprosthesis, Model 2650 (Aortic) |
Edwards Lifesciences LLC Irvine, Ca 92614 |
Approval of the post-approval study for the device. |
| P020009/S005 1/24/03 Special |
Express and Express2 Monorail and Over-the-Wire Coronary Stent Systems |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Approval for changes to the Instructions for Use (IFU) to more clearly instruct the user regarding the methods for removal of an unexpanded stent. |
30-Day Notices (135 Day Supplement was not required)
| APPLICATION NUMBER / DATE of APPROVAL |
DEVICE TRADE NAME |
COMPANY NAME |
DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P790025/S008 1/17/03 |
Abbott HBe (rDNA) EIA |
Abbott Laboratories Abbott Park, IL 60064 |
Changes to manufacturing process, test method additions, and specification changes. |
| P930031/S015 1/10/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change from a manual to an automatic cleaning and passivation process. |
| P930031/S016 1/17/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change in the manufacturing process of the WALLSTENT Delivery System which involves the replacement of the catheter hub bond to stainless steel tube bond cure time with a reduced set time. |
| P940019/S013 1/10/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change from a manual to an automatic cleaning and passivation process. |
| P940019/S014 1/17/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change in the manufacturing process of the WALLSTENT Delivery System which involves the replacement of the catheter hub bond to stainless steel tube bond cure time with a reduced set time. |
| P980033/S004 1/10/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change from a manual to an automatic cleaning and passivation process. |
| P980033/S005 1/17/03 |
WALLSTENT® (Tips, Iliac, Venous) Endoprosthesis with Unistep™ Plus Delivery System |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Change in the manufacturing process of the WALLSTENT Delivery System which involves the replacement of the catheter hub bond to stainless steel tube bond cure time with a reduced set time. |
| P000039/S003 1/15/03 |
AMPLATZER® Septal Occluder and AMPLATZER® 45 º Delivery and Exchange Systems |
AGA Medical Corporation Golden Valley, MN 55427 |
Change in the manufacturing process to obtain an alternate supplier for components used with the AMPLATZER Septal Occluder and Delivery Exchange Systems. |
| P000052/S015 1/17/03 |
GALILEO® and GALILEO® III Intravascular Radiotherapy System |
Guidant Corporation Houston, TX 77054 |
Change to the manufacturing process for mounting the FPGA chip of the GALILEO® and GALILEO® III Intravascular Radiotherapy System. |
| P020004/S001 1/30/03 |
Gore EXCLUDER™ Bifurcated Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Alternate Vendor for the Leg Hold ring used in the manufacture of the Gore EXCLUDER Bifurcated Endoprosthesis. |
| P020009/S004 1/22/03 |
Express and Express2 Coronary Stent Systems |
Boston Scientific Scimed, Inc. Maple Grove, MN 55311 |
Alternate laser cutting speed to manufacture the stent component for the Express and Express2 Coronary Stent Systems. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 36
Summary of PMA Originals Under Review
Total Under Review: 69
Total Active: 31
Total On Hold: 38
Number Greater Than 180 Days: 1
Summary of PMA Supplements Under Review
Total Under Review: 260
Total Active: 140
Total On Hold: 120
Number Greater Than 180 Days: 2
Summary of All PMA Submissions Received
Originals: 2
Supplements: 45
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 36
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 79.5 Days
FDA Time: 60.9 Days MFR Time: 18.6 Days
Updated 2/07/2003
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