Premarket Approval Decisions for March 2001

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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PMA Final Decisions Rendered for March 2001

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 for March 2001. 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

P990026

3/22/01

GlucoWatch® Automatic Glucose Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for the GlucoWatch® Automatic Glucose Biographer. The device is indicated for: The GlucoWatch® Automatic Glucose Biographer is a glucose monitoring device indicated for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) with diabetes. The device is intended for use by patients at home and in health care facilities. The GlucoWatch Biographer is indicated for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. The Biographer is indicated for use in the detection and assessment of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments, which may minimize these excursions. Interpretation of Biographer results should be based on the trends and patterns seen with several sequential readings over time.

P990038

3/30/01

DiaSorin ETI-MAK-2 PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the DiaSorin ETI-MAK-2 PLUS Assay. The device is indicated for: ETI-MAK-2 PLUS is an in vitro enzyme immunoassay (EIA) intended for use in the qualitative determination of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, citrate or heparin). The ETI-MAK-2 PLUS is intended for manual use and with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. The detection of HBsAg is indicative of a laboratory diagnosis for hepatitis B virus (HBV) infection, either acute or chronic. Further HBV serological marker testing is required to define the specific disease state. The ETI-MAK-2 PLUS assay’s performance has not been established for the monitoring of HBV disease or therapy. This assay has not been FDA-approved for the screening of blood or plasma donors.

P990041

3/30/01

DiaSorin ETI-AB-EBK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the DiaSorin ETI-AB-EBK PLUS Assay. The device is indicated for: ETI-AB-EBK PLUS is an in vitro enzyme immunoassay (EIA) intended for use in the qualitative detection of total antibodies to hepatitis B e antigen (anti-HBe) in human serum or plasma (EDTA, citrate or heparin). The ETI-AB-EBK PLUS is intended for manual use and with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. The detection of anti-HBe is indicative of laboratory diagnosis for seroconversion and progression to hepatitis B virus (HBV) clearance. A reactive test is presumptive laboratory evidence of HBV seroconversion. Further HBV serological marker testing is required to define the specific disease state. The anti-HBe assay’s performance has not been established for the monitoring of HBV disease or therapy.

P990042

3/30/01

DiaSorin ETI-AB-AUK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the DiaSorin ETI-AB-AUK PLUS Assay. The device is indicated for: ETI-AB-AUK PLUS is an in vitro enzyme immunoassay (EIA) intended for the qualitative detection of antibodies to hepatitis B surface antigen (anti-HBs) in human serum or plasma (EDTA, citrate or heparin). The ETI-AB-AUK PLUS is intended for manual use only. The detection of anti-HBs is indicative of laboratory diagnosis for seroconversion from hepatitis B virus (HBV) infection. Anti-HBs is also used to assess laboratory diagnosis of past exposure to hepatitis B in potential hepatitis B vaccine recipients and to determine the presence of an immune response to vaccine recipients. The anti-HBs assay’s performance has not been established for the monitoring of HBV disease or therapy.

P990044

3/30/01

DiaSorin ETI-CORE-IGMK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the DiaSorin ETI-CORE-IGMK PLUS Assay. The device is indicated for: ETI-CORE-IGMK PLUS is an in vitro enzyme immunoassay (EIA) intended for use in the qualitative determination of IgM antibody to hepatitis B core antigen (IgM anti-HBc) in human serum or plasma (EDTA, citrate or heparin). The ETI-CORE-IGMK PLUS is intended for manual use and with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. The presence of IgM anti-HBc, in the presence of total antibody to HBc (anti-HBc), is indicative of a laboratory diagnosis for acute infection. The absence of IgM anti-HBc, in the presence of total anti-HBc, is indicative of a laboratory diagnosis for recovery from HBV infection. Further HBV serological marker testing is required to define the specific disease state. The ETI-CORE-IGMK PLUS assay’s performance has not been established for the monitoring of HBV disease or therapy. This assay has not been FDA-approved for the screening of blood or plasma donors.

P990045

3/30/01

DiaSorin ETI-AB-COREK PLUS Assay

DiaSorin, Inc.

Stillwater, MN

55082

Approval for the DiaSorin ETI-AB-COREK PLUS Assay. The device is indicated for: ETI-AB-COREK PLUS is an in vitro enzyme immunoassay (EIA) intended for use in the qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum or plasma (EDTA, citrate or heparin). The ETI-AB-COREK PLUS is intended for manual use and with the Biochem Immunosystems Labotech/ETI-LAB automated instrument. The detection of total anti-HBc is indicative of a laboratory diagnosis for exposure to hepatitis B virus (HBV) infection. Further HBV serological marker testing is required to define the specific disease state. The ETI-AB-COREK PLUS assay’s performance has not been established for the monitoring of HBV disease or therapy.

PMA/PDP SUPPLEMENTAL APPROVALS
APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
N16895/S087 3/26/01 180-Day	SOFLENS® (polymacon) Contact Lenses for Therapeutic Use (Plano T and Optima® FW) Clear and Visibility Tinted	Bausch & Lomb Rochester, NY 14603	Approval for 1) The establishment of separate labeling for the therapeutic use indication; and, 2) Combining the Package Insert and Professional Fitting Guide into a single reference intended for the eye care practitioner. The devices, as modified, will be marketed under the trade names SOFLENS® (polymacon) Contact Lenses (Plano T) and Bausch & Lomb Optima® FW (polymacon) Visibility Tinted Contact Lenses. The lenses are indicated for use in the treatment and management of acute and chronic corneal pathologies such as bullous keratopathy, corneal ulcers and erosion, dry eyes, keratitis, protection of cornea during and after surgery, accidental or surgical trauma, and entropion. When prescribed for therapeutic use, the SOFLENS® (polymacon) Contact Lenses (Plano T and Optima® FW) may be worn for daily or extended wearing periods. The eye care practitioner should recommend either single-use disposable wear or a schedule of periodic replacement, and should provide instructions for cleaning, disinfection, and replacement of the lenses. The lenses may be disinfected using a chemical disinfection system. The lens should be inserted and removed only as the eye care practitioner has instructed.
N50510/S140 3/9/01 180-Day	Vitek® 2 Gram Positive Susceptibility Test for Minocycline	BioMérieux, Inc. Hazelwood, MO 63042	Approval for the addition of the antibiotic minocycline at concentrations of 0.125, 0.5, and 1 m g/ml to the Vitek® 2 Gram Negative Susceptibility Test System. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in Vitek® 2 Gram Positive Susceptibility Test Cards for the susceptibility testing of gram positive isolates to minocycline in the rate of £ 0.5 to ³ 16 m g/ml.
P810002/S055 3/16/01 180-Day	SJM Mechanical Heart Valve, Master Series Coated Aortic Valved Graft	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for a new manufacturing site located at Steris Isomedix, Vega Alta, Puerto Rico.
P810046/S204 3/2/01 Real-Time	PowerSail™ and HighSail™ Coronary Dilatation Catheters	Guidant Corporation Temecula, CA 92589	Approval for new catheter models. The devices, as modified will be marketed under the trade names PowerSail™ and HighSail™ Coronary Dilatation Catheters and are indicated for: 1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. 2) balloon dilation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction. 3) balloon dilatation of the ACS MULTI-LINK™, ACS MULTI-LINK DUET™, ACS MULTI-LINK TRISTAR™, ACS MULTI-LINK TETRA™ or ACS MULTI-LINK ULTRA™ stents after implantation.
P830045/S075 3/2/01 Real-Time	Programmer Software Model 3307 v2.1	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Programmer Software Model 3307 v2.1.
P850007/S026 3/9/01 180-Day	Physio-Stim/Spinal Stim Bone Growth Stimulators	Orthofix, Inc. McKinney, TX 75069	Approval for a manufacturing site located at Orthofix, Inc., McKinney, Texas.
P880086/S082 3/2/01 Real-Time	Programmer Software Model 3307 v2.1	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Programmer Software Model 3307 v2.1.
P900023/S034 3/12/01 180-Day	ABIOMED® BVS 5000® Bi-Ventricular Support System	ABIOMED, Inc. Danvers, MA 01923	Approval to revise the labeling to include cannulation of the left ventricular apex with any of the atrial cannulae.
P900023/S035 3/15/01 180-Day	BVS 5000 Bi-Ventricular Support System	Abiomed, Inc. Danvers, MA 01923	Approval for a new manufacturing site located at Abiomed, Inc., Danvers, Massachusetts.
P900056/S060 3/21/01 180-Day	Rotablator® RotaLink Rotational Angioplasty System and RotaLink™ Plus with Exchangeable Catheter	Boston Scientific Corporation Redmond, WA 98052	Approval for a new manufacturing facility located at Boston Scientific Cork Ltd. (BSCL), Cork, Ireland and sterilization facility located at Isotron Ireland Ltd., Offaly, Ireland.
P900061/S043 3/15/01 Real-Time	Vision Software Series 4.0	Medtronic, Inc. Shoreview, MN 55126	Approval for the programming software to be used with the Medtronic GEM (Model 9962 Software) ICD System. The device, as modified, will be marketed under the trade name of Medtronic Vision Software Series 4.0.
P910023/S051 3/2/01 Real-Time	Programmer Software Model 3307 v2.1	St. Jude Medical, Inc. Sylmar, CA 91342	Approval for the Programmer Software Model 3307 v2.1.
P910071/S005 3/22/01 180-Day	ADATO SIL-OIL 5000 Silicone Oil	Bausch & Lomb Surgical Irvine, CA 92618	Approval for the following changes: 1) Change of manufacturing site to Pharm Pur GmbH, Augsburg, Germany. 2) Specification revisions: a) change to the following specifications: viscosity; resistivity; and content of oligosiloxanes; and b) addition of the following specifications and their test methods: content of catalyst; heavy metals; endotoxins; acid content; cytotoxicity and acetone. 3) Change in the following method: Determination of contend of OH-end groups (changed from HNMR to Karl Fisher Titration).
P920004/S014 3/13/01 180-Day	VasoSeal Extra Security (ES) Device	Datascope Coporation Mahwah, NJ 07430	Approval to manufacture the VasoSeal ES Device at a new facility located at Datascope Corp., Mahwah, New Jersey.
P920014/S014 3/2/01 180-Day	HeartMate® VE LVAS	Thermo Cardiosystems, Inc. Woburn, MA 01888	Approval to change the method of connecting the percutaneous controller cable (P/N 28702) to the VE System Controller (C/N 1216).
P920048/S003 3/9/01 180-Day	Rapid fFN for the TLi™ System	Adeza Biomedical Corporation Sunnyvale, CA 94089	Approval for the following: 1) a change in the calibration procedure that allows for extended calibration, accomplished with a software modification and no longer requiring the use of the fFN Positive Reference Calibrator; and 2) the addition of a quality control component, the TLi QC Cassette, for the TLi Analyzer coupled with a decrease in frequency of testing liquid controls.
P930016/013 3/19/01 180-Day	VISX STAR S2 and S3 Excimer Laser Systems	VISX, Inc. Santa Clara, CA 95051	Approval to add an 8 mm blend zone that increases the overall diameter of the ablation zone from 6.5 to 8.0 mm.
P960011/S004 3/23/01 180-Day	Biolon™ 1% Sodium Hyaluronate For Ophthalmic Surgery	Bio-Technology General Corporation Iselin, NJ 08830	Approval for CIBA Vision to market Biolon™ 1% sodium hyaluronate for ophthalmic surgery in the United States under the trade name "Univisc".
P960011/S006 3/8/01 135-Day	BioLon™ 1% Sodium Hyaluronate	BioTechnology General Corp. Iselin, NJ 08830	Approval to change the Cleaning in Place and Sterilization in Place processes and introduce an Equilibration step in the manufacturing of BioLon™.
P960036/S004 3/16/01 180-Day	Memory Lens® UV Absorbing Hydrophilic Posterior Chamber IOL	Ciba Vision Corporation Duluth, GA 30097	Approval for the change of the vial material from glass to plastic for the Memory Lens® IOL.
P970007/S002 3/30/01 Special	IMX Tacrolimus II	Abbott Laboratories Abbott Park, IL 60064	Approval for a change to the current labeling for the device per 21 CFR 814.39(d)(2). The current package insert states "Hematocrit values ranging from 25 to 45% resulted in less than 12% error in detecting tacrolimus." The package insert will be modified to state "Hematocrit interference was evaluated by spiking known amounts of tacrolimus into pooled, whole blood samples diluted with saline. Hematocrit values ranging from 25 to 45% resulted in less than 31% error in detecting tacrolimus.
P970012/S010 3/8/01 Real-Time	Kappa 400 Pacing System	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Kappa 650 Series Pulse Generators and Vision Software Series 4.0.
P970020/S028 3/2/01 180-Day	ACS Multi-Link RX and OTW Ultra™ Coronary Stent Systems	Guidant Corporation Temecula, CA 92589	Approval for a modified precaution statement in the Instructions for Use of the ACS Multi-Link RX and OTW Ultra™ Coronary Stent Systems.
P970051/S013 3/2/01 180-Day	Nucleus 24 Contour Cochlear Implant System	Cochlear Corporation Englewood, Co 80112	Approval for a new headset, HS9, which consists of a label microphone, a transmitting coil, and a cable designed to connect directly to the Sprint speech processor.
P970053/S005 3/15/01 180-Day	Nidek EC-5000 Excimer Laser System	Nidek Technologies, Inc. Pasadena, CA 91105	Approval to modify the device by the addition of security software and a hardware block to preclude the use of unapproved software.
P980009/S006 3/16/01 180-Day	Magic Wallstent Endoprosthesis	Boston Scientific Scimed Maple Grove, MN 55311	Approval for a new manufacturing site located at Boston Scientific Ireland Ltd., Galway, Ireland.
P980016/S017 3/15/01 Real-Time	Vision Software Series 4.0	Medtronic, Inc. Shoreview, MN 55126	Approval for the programming software to be used with the Medtronic GEM DR (Model 9960 Software), GEM II VR (Model 9965 Software), and GEM II DR (Model 9964 Software) ICD Systems. The device, as modified, will be marketed under the trade name of Medtronic Vision Software Series 4.0.
P980035/S009 3/8/01 Real-Time	Kappa 700/600 Pacing System	Medtronic, Inc. Minneapolis, MN 55432	Approval for the Kappa 650 Series Pulse Generators and Vision Software Series 4.0.
P980046/S004 3/21/01 180-Day	Home Access Hepatitis C Check Test	Home Access Health Corporation Hoffman Estates, IL 60195	Approval for a manufacturing site located at Home Access Health Coporation, Hoffman Estates, Illinois.
P990001/S006 3/7/01 Real-Time	ProVit VSA02 v6.1 Programming Software for the Dema, Diva, and selection AFm families of pulse generators	Vitatron, Inc. Minneapolis, MN 55459	Approval for the software version ProVit VSA02 v6.1 Dema, Diva and selection of AFm pulse generators.
P990009/S005 3/15/01 Real-Time	FloSeal Matrix (AKA Proceed) Hemostatic Sealant	Fusion Medical Technologies, Inc. Fremont, CA 94555	Approval for a modification kit configuration without the thrombin component.
P990037/S002 3/14/01 Real-Time	Vascular Solutions Duett Model 1000 Sealing Device	Vascular Solutions, Inc. Minneapolis, MN 55441	Approval for changes to the instructions for use manual.
P990037/S003 3/22/01 Real-Time	Vascular Solutions Duett Model 1000 Sealing Device	Vascular Solutions, Inc. Minneapolis, MN 55441	Approval for changes to the instructions for use manual to include the outcome data (registry results) regarding patients treated with platelet GP IIb/IIIa inhibitors.
P990078/S004 3/16/01 180-Day	Sunrise Technologies Hyperion™ Holmium Laser System for Laser Thermal Keratoplasty (LTK)	Sunrise Technologies, Inc. Fremont, CA 94538	Approval for a software modification to the eye tracker.
P990086/S002 3/30/01 Real-Time	HealthTronics OssaTron®	HealthTronics, Inc. Marietta, GA 30062	Approval for certain ergomonic and safety design changes and a device performance change, i.e., providing the option of using 4 Hz frequency of the shock wave delivery, as well as labeling changes in the Operator Manual to provide adequate instructions and information about these changes. The device, as modified, will be marketed under the trade name HealthTronics OssaTron® and is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic proximal plantar fasciitis that have failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as pain in the area of insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for six months or more.
P000009/S001 3/5/01 180-Day	Tachos DR Implantable Cardioverter Defibrillator (ICD) System	Biotronik, Inc. Lake Oswego, OR 97035	Approval for a new ICD System which includes the following: Tachos DR ICD (Model 335572), Tachos DR Test Housing (Model 122068), and Tachos DR and TMS 1000 Application Software I-HDR.0.U (Model 334802). The device, as modified, will be marketed under the trade name Tachos DR Implantable Cardioverter Defibrillator System and is indicated for ventricular antitachycardia pacing and ventricular defibrillation, for automated treatment of life-threatening ventricular arrhythmias.
P000022/S002 3/15/01 180-Day	BeStent™ 2 with Discrete Technology™ Rapid Exchange Coronary Stent Delivery System	Medtronic AVE, Inc. Santa Rosa, CA 95403	Approval for the post-approval study protocol for the BeStent™ 2 with Discrete Technology™ Rapid Exchange Coronary Stent Delivery System.

30-DAY NOTICES (135 Day Supplement Was Not Required)
APPLICATION NUMBER & LTR DATE DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP
P860019/S169

3/27/01

Boston Scientific Scimed Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change from an internal particulate maximum level to an internal particulate action level for the finished product.

P880027/S058

3/27/01

Boston Scientific Scimed Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change from an internal particulate maximum level to an internal particulate action level for the finished product.

P880065/S005

3/27/01

Boston Scientific Corporation Aortic Valvuloplasty Balloon Dilatation Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change from an internal particulate maximum level to an internal particulate action level for the finished product.

P930038/S030

3/12/01

Angio-Seal™ Vascular Closure Device, 8F/6F

St. Jude Medical, Inc.

Minnetonka, MN

55345

Removal of the HEPA work stations in the Puerto Rico manufacturing facility and to change the environmental monitoring procedure from a quarterly process to a monthly process.

P950018/S005

3/27/01

Perfluoron®

Alcon Research, Ltd.

Fort worth, TX

76134

Eliminate the water content testing and the odor check on the perfluoro-n-octane raw material.

P970035/S024

3/19/01

S670 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems, S660 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Change from an oil-base coolant used during ring machining process to a water-base coolant, and proposes to change the alcohol and HFE solvent cleaner used during ring machining to a water-base cleaning solution for both the S670 and S660 products.

P970035/S025

3/19/01

S670 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems, S660 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Option to use an automated filling and evacuating coating chamber, that then automatically transfers the catheters to the curing chamber.

P970061/S010

3/27/01

Scimed Radius™ Coronary Stent with Delivery Stystem

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change from an internal particulate maximum level to an internal particulate action level for the finished product.

P980001/S029

3/27/01

NIR® Premounted Stent Delivery Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change form an internal particulate maximum level to an internal particulate action level for the finished product.

P000014/S001

3/20/01

Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators

Ortho-Clinical Diagnostic, Inc.

Rochester, NY

14626

Change to test and release limits that are applied to the results from in-house controls used during the testing and release process for this product.

P000018/S010

3/9/01

Novoste™

Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Change in the manufacturing method used in cutting the delivery catheter, from a manual to an automated process.

P000022/S004

3/19/01

BeStent™ 2 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Option to use an automated filling and evacuating coating chamber, that then automatically transfers the catheters to the curing chamber.

Summary of PMA Originals & Supplements Approved
Originals: 6
Supplements: 37

Summary of PMA Originals Under Review
Total Under Review: 78
Total Active: 39
Total On Hold: 39
Number Greater Than 180 Days: 0

Summary of PMA Supplements Under Review
Total Under Review: 241
Total Active: 139
Total On Hold: 102
Number Greater Than 180 Days: 2

Summary of All PMA Submissions Received
Originals: 7
Supplements: 50

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 37
Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 88.5 days

FDA Time: 65.5 Days MFR Time: 23 Days

Updated 4/9/2001

horizonal rule

Center for Devices and Radiological Health / CDRH

30-DAY NOTICES (135 Day Supplement Was Not Required)
APPLICATION NUMBER & LTR DATE	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP
P860019/S169 3/27/01	Boston Scientific Scimed Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change from an internal particulate maximum level to an internal particulate action level for the finished product.
P880027/S058 3/27/01	Boston Scientific Scimed Percutaneous Transluminal Coronary Angioplasty(PTCA) Catheters	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change from an internal particulate maximum level to an internal particulate action level for the finished product.
P880065/S005 3/27/01	Boston Scientific Corporation Aortic Valvuloplasty Balloon Dilatation Catheter	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change from an internal particulate maximum level to an internal particulate action level for the finished product.
P930038/S030 3/12/01	Angio-Seal™ Vascular Closure Device, 8F/6F	St. Jude Medical, Inc. Minnetonka, MN 55345	Removal of the HEPA work stations in the Puerto Rico manufacturing facility and to change the environmental monitoring procedure from a quarterly process to a monthly process.
P950018/S005 3/27/01	Perfluoron®	Alcon Research, Ltd. Fort worth, TX 76134	Eliminate the water content testing and the odor check on the perfluoro-n-octane raw material.
P970035/S024 3/19/01	S670 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems, S660 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Change from an oil-base coolant used during ring machining process to a water-base coolant, and proposes to change the alcohol and HFE solvent cleaner used during ring machining to a water-base cleaning solution for both the S670 and S660 products.
P970035/S025 3/19/01	S670 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems, S660 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Option to use an automated filling and evacuating coating chamber, that then automatically transfers the catheters to the curing chamber.
P970061/S010 3/27/01	Scimed Radius™ Coronary Stent with Delivery Stystem	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change from an internal particulate maximum level to an internal particulate action level for the finished product.
P980001/S029 3/27/01	NIR® Premounted Stent Delivery Systems	Boston Scientific Scimed, Inc. Maple Grove, MN 55311	Change form an internal particulate maximum level to an internal particulate action level for the finished product.
P000014/S001 3/20/01	Vitros Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrators	Ortho-Clinical Diagnostic, Inc. Rochester, NY 14626	Change to test and release limits that are applied to the results from in-house controls used during the testing and release process for this product.
P000018/S010 3/9/01	Novoste™ Beta-Cath™ System	Novoste Corporation Norcross, GA 30093	Change in the manufacturing method used in cutting the delivery catheter, from a manual to an automated process.
P000022/S004 3/19/01	BeStent™ 2 With Discrete Technology™ Over-the-Wire and Rapid Exchange Coronary Stent Systems	Medtronic AVE, Inc. Santa Rosa, CA 95403	Option to use an automated filling and evacuating coating chamber, that then automatically transfers the catheters to the curing chamber.