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PMA Final Decisions Rendered for October 2002

P800012/S010

10/9/02

Special

Drilac Cubes and Granules

Kensey Nash Corporation

Exton, PA

19341

Approval for changes to the directions for use labeling.

P830039/S011

10/29/02

180-Day

Omnicarbon™ Cardiac Valve Prosthesis, Model 3313 (aortic) and Model 3523 (mitral)

MedicalCV, Inc.

Inver Grove Heights, MN

55077

Approval for the Omnicarbon Cardiac Valve Prosthesis in the additional size of 21 mm of the Model 3313 (aortic) and size 25 mm of the Model 3523 (mitral).  The supplement requested approval of these sizes as an addition to the existing, approved (July 26, 2001; P830039/S007) product line of aortic sizes 23, 25, 27 and 29 mm, and mitral sizes 27, 29, 31, and 33 mm.  The device is indicated for the replacement of malfunctioning native or prosthetic aortic and mitral valves.

P830055/S082

10/4/02

180-Day

LCS® Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for an additional sterilization facility located at Isotron, Berkshire, England.

P840001/S061

10/31/02

180-Day

Itrel® II, Itrel® 3, Synergy™ and Synergy Versitrel™ Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 8870 N’Vision Application Card.  The Model 8870 N’Vision Application Card is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.

P840001/S065

10/3/02

Real-Time

Synergy™ and Synergy Versitrel™ Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 3898 Pisces-Octad® Lead and the Model 7471 Octapolar extension which are indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.

P840001/S066

10/29/02

Real-Time

Itrel® 3, Synergy™ and Synergy Versitrel™ Neurostimulators

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 7489 Extension which is indicated as an aid in the management of chronic, intractable pain of the trunk or limbs.

P840045/S006

10/25/02

180-Day

Dilapan-S™

J.C.E.C. company

Kendall Park, NJ

08824

Approval for a new device design and new manufacturing location.  The device, as modified and with revised labeling, will be marketed under the trade name Dilapan-S™ and is indicated for dilatation of the cervix uteri prior to termination of pregnancy up to 16 weeks gestation.  A single Dilapan-S™ is inserted into the endocervical canal and may remain in situ for up to four hours.  The device will be manufactured at a new facility located at GelMed International, in the Czech Republic and sterilized at a contract sterilization facility located at Bioster A.S., in the Czech Republic.

P860004/S052

10/29/02

180-Day

Medtronic® N’Vision Programming System and SynchronMed® Application Software

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic® N’Vision Programming System and SynchroMed® application software.

P860004/S053

10/9/02

Special

SynchroMed EL Programmable Pump

Medtronic, Inc.

Minneapolis, MN

55432

Approval for changes to the SynchroMed EL Programmable Pump Technical Manual for new warnings and information regarding inflammatory mass, pump overpressurization, diathermy and other text changes.

P860004/S054

10/11/02

Real-Time

Medtronic Intrathecal Catheter Model 8731, Medtronic Infusion Pump System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the following changes to Intrathecal Catheter Model 8731:  1) pre-attached two-piece connector/anchor  2) catheter tubing material with improved physical properties,  3) catheter tip with improved radiopacity,  4) longer introducer needle with depth markings,  5) revision kits (Models 8596 and 8598), and  6) catheter passer kits (Model 8583 & 8686).  The device, as modified, will be marketed under the trade name Medtronic Model 8731 Closed-tip Intrathecal Catheter and is indicated for use with the Medtronic® SynchroMed™ or IsoMed™ Implantable infusion pump systems to administer parenteral drugs.

P860019/S180

10/1/02

180-Day

SCIMED® NC RANGER™ Percutaneous Transluminal Coronary Angioplasty Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for minor changes to the balloon catheter compliance charts in the product labeling.

P860019/S182

10/1/02

180-Day

Quantum™ Maverick™ Monorail™ and Over-the-Wire (OTW) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the Quantum Maverick Monorail and OTW PTCA Catheters and approval for an additional sterilization facility, Cosmed of RI, Coventry, Rhode Island.  The Quantum Maverick Monorail & OTW PTCA Catheters are available in lengths of 8, 12, 15, 20 and 30 mm, with diameters ranging from 2.00 to 4.00 mm in ¼ mm increments and 4.50 to 5.00 mm in ½ mm increments (except for the 30 mm length).  The devices, as modified, are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for the post delivery expansion of balloon expandable stents.

P860019/S183

10/24/02

180-Day

Maverick™ XL Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (Monorail)

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for Maverick™ XL Percutaneous Transluminal Coronary Angioplasty PTCA) Catheters (Monorail) and approval for an additional sterilization facility, Cosmed of RI, Coventry, Rhode Island.  The Maverick™ XL PTCA Catheters are available in lengths of 15 and 20 mm, with diameters of 4.0, 4.5, 5.0, 5.5 and 6.0 mm.  The devices, as modified, are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft for the purpose of improving myocardial perfusion and for the post delivery expansion of balloon expandable stents.

P860019/S188

10/24/02

180-Day

Maverick Over the Wire (OTW) and Ranger PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate packaging and sterilization facility located at Cosmed Group, Inc., Coventry, Rhode Island.

P870072/S017

10/09/02

180-Day

Thoratec® Ventricular Assist Device (VAD) System

Thoratec Laboratories Corporation

Pleasanton, CA

94588

Approval to expand the indications for use for the TLC-II Portable VAD Driver System to include the transportation of VAD patients via ground ambulance.

P870072/S020

10/7/02

180-Day

Thoratec® Ventricular Assist Device (VAD) System

Thoratec Laboratories, Corporation

Pleasanton, CA

94588

Approval for a change in the supplier of the microprocessor used on the controller board in the TLC-II Portable VAD Driver.

P870072/S022

10/29/02

Special

Thoratec® Ventricular Assist Device (VAD) System

Thoratec Laboratories, Corporation

Pleasanton, CA

94588

Approval for the addition of inspections, test methods, and specifications for the controller boards for the TLC-II Portable VAD Driver.

P890055/S013

10/18/02

180-Day

Model 3000 Series Implantable Infusion Pumps

Codman & Shurtleff, Inc.

Walpole, MA

02081

Approval for the Indications for Use to include Glycerin Injection as an infusate for use with patients who are receiving continuous Hepatic Arterial FUdR Chemotherapy with the Arrow International Model 3000 Series of Implantable Infusion Pumps to keep the catheter patent or to extend the refill interval for patients who require therapy or withdrawal.

P930014/S010

10/7/02

180-Day

AcrySof® Single-Piece Posterior Chamber Intraocular Lens Model SA60AT

Alcon Laboratories

Fort Worth, TX

76134

Approval to extend the Model SA60AT power range from +6.0D through +34.0D to +6.0 through +40.0D.

P950032/S034

10/15/02

180-Day

Apligraf

Organogenesis, Inc.

Canton, MA

02021

Approval for the introduction of a sodium hydroxide step into the bovine collagen production method and the discontinuation of viral testing on individual lots of collagen.

P950034/S022

10/25/02

Real-Time

Seprafilm® Adhesion Barrier

Genzyme Biosurgery

Cambridge, MA

02139

Approval for revised labeling for Seprafilm Adhesion Barrier to reflect the interim findings of the study approved under G980066, “A Prospective, Randomized, Multicenter, Controlled Evaluation of the Efficacy and Safety of Seprafilm® Bioresorbable Membrane in the Reduction of the Incidence of Bowel Obstruction of General Surgery.”  The device, with the modified labeling, will be marketed under the trade name Seprafilm® Adhesion Barrier, and is indicated for use in patients undergoing abdominal or pelvic laparotomy as an adjunct intended to reduce the incidence, extent, and severity of postoperative adhesions between the abdominal wall and the underlying viscera such as omentum, small bowel, bladder and stomach, and between the uterus and surrounding structures such as tubes and ovaries, large bowel, and bladder.

P960009/S025

10/31/02

180-Day

Soletra™ and Itrel® II Neurostimulators for Deep Brain Stimulation (DBS)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 8870 N’Vision Application Card.  The Model 8870 N’Vision Application Card is an accessory to the Soletra™ and Itrel® II neurostimulators for DBS.

P960009/S026

10/31/02

Real-Time

Medtronic Model 7482 DBS® Extension

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the following changes to the approved Model 7482 DBS® Extension; combine low profile design and technology with a low impedance conductor, change the coating used on the outside diameter to siloxane, add a new torque wrench to the extension package, and add a new Model 3550-25 Boots Accessory Kit.

P960040/S027

10/7/02

180-Day

Model 2844 Application Software, Version 3.5

Guidant Corporation

St. Paul, MN

55112

Approval for Model 2844 Software, Version 3.5.

P970018/S004

10/1/02

180-Day

PrepStain™ System (formerly AutoCyte® PREP System)

TriPath Imaging, Inc.

Redmond, WA

98052

Approval for stopping the post-approval reporting requirement for a direct-to-vial study for the PrepStain System.

P970035/S038

10/15/02

180-Day

S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV2000 balloon, S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV100 balloon, S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV2000 balloon, S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV100 balloon

Medtronic AVE

Santa Rosa, CA

95403

Approval for the following trade names and expanded device indications: 

The S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV2000 balloon is indicated for: “improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length ≤30 mm) in native coronary arteries and saphenous vein grafts with reference vessel diameters ranging from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.” 

The S7 with Discrete Technology™ Over-the-Wire Coronary Stent System with the AV100 balloon is indicated for: “improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length ≤30 mm) in native coronary arteries and saphenous vein grafts with reference vessel diameters ranging from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.” 

The S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV2000 balloon is indicated for: “improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length ≤30 mm) in native coronary arteries and sapheous vein grafts with reference vessel diameters ranging from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.  The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only.  The Rapid Exchange Stent Delivery System is not intended for use as a stand-alone PTCA perfusion catheter.” 

The S7 with Discrete Technology™ Rapid Exchange Coronary Stent System with the AV100 balloon is indicated for: “improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length ≤30 mm) in native coronary arteries and sapheous vein grafts with reference vessel diameters ranging from 3.0 mm to 4.0 mm through direct stenting or predilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.  The rapid exchange delivery system will allow for perfusion at an average rate of 2 cc/min at nominal pressure during the 15-30 second stent deployment procedure only.  The Rapid Exchange Stent Delivery System is not intended for use as a stand-alone PTCA perfusion catheter.” 

P970035/S042

10/2/02

180-Day

Medtronic AVE S660 Coronary Stent with Zipper Delivery System and S7 Coronary Stent with Zipper Delivery System

Medtronic AVE

Santa Rosa, CA

95403

Approval for the Medtronic AVE S660 Coronary Stent with Zipper Delivery System and S7 Coronary Stent with Zipper Delivery System.

P970035/S043

10/28/02

180-Day

Medtronic AVE S7 Coronary Stent with Zipper Delivery System

Medtronic AVE

Santa Rosa, CA

95403

Approval for the addition of two new indications for the Medtronic AVE S7 Coronary Stent with Zipper Delivery System, specifically for direct stenting and for the treatment of saphenous vein grafts.  The device, as modified, will be marketed under the trade name Medtronic AVE S7 Coronary Stent with Zipper Delivery System and is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo lesions (length <=30 mm) in native coronary arteries and saphenous vein grafts with reference vessel diameters ranging from 3.0 mm to 4.0 mm using direct stenting or pre-dilatation.  Long-term outcome (beyond 180 days) for this permanent implant is unknown at present.

P970043/S010

10/18/02

Panel

LADARVision® 4000 Excimer Laser System

Alcon Laboratories, Inc.

Orlando, FL

32826

Approval for the LADARVision 4000 Excimer Laser System.  This device uses a 6.5 mm optical zone, a 9.0 mm treatment zone, is locked-out for treatments above -7.0 diopters (D) as measured by manifest refraction, and is indicated for wavefront-guided laser assisted in-situ keratomileusis (LASIK):  1) for the reduction or elimination of myopia up to -7.00 D with less than -0.50 D of astigmatism at the spectacle plane;  2) in patients who are 21 years of age or older; and  3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0.50 D.

P970053/S007

10/28/02

180-Day

Nidek EC-5000 Excimer Laser System

Nidek Technologies, Inc.

Pasadena, CA

91105

Approval for the addition of a Windows Operating System and Eye Tracking System to the Nidek EC-5000 Excimer Laser System.

P970061/S017

10/29/02

Real-Time

RADIUS™ Coronary Stent and Delivery Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for an alternate packaging configuration.

P980041/S001

10/1/02

180-Day

ACCESS® AFP Assay on the ACCESS® 2 Immunoassay System

Beckman Coulter, Inc.

Chaska, MN

55318

Approval for expanding the use of the AFP Immunoassay on the ACCESS® 2 Analyzer.  The device, as modified, will be marketed under the trade name ACCESS® AFP Immunoassay System and is indicated for the quantitative determination 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 used in conjunction with other diagnostic tools such as ultrasound and amniography.

P980043/S002

10/28/02

180-Day

Hancock® II Porcine Bioprosthesis, Model T505 (aortic)

Medtronic, Inc.

Santa Ana, CA

92705

Approval for modifications to the valve holders for the Hancock® II Bioprosthesis.  The holders are to be used with the following approved valve models and sizes: Hancock® II Porcine Bioprosthesis, Model T505 (aortic, sizes 21, 23, 25, 27, and 29 mm.  These aortic valves are indicated for the replacement of malfunctioning native or prosthetic aortic valves.

P990020/S011

10/24/02

180-Day

Medtronic AVE AneuRx Stent Graft System

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for a new manufacturing facility located at Medtronic AVE, Inc., Santa Rosa, California.

P990064/S007

10/28/02

180-Day

Mosaic® Porcine Bioprosthesis, Model 305 (aortic)

Medtronic, Inc.

Santa Ana, CA

92705

Approval for modifications to the valve holders for the Mosaic® Bioprosthesis.  The holders are to be used with the following approved valve models and sizes: Mosaic® Porcine Bioprosthesis, Model 305 (aortic, sizes 19, 21, 23, 25, 27, and 29 mm.  These aortic valves are indicated for the replacement of malfunctioning native or prosthetic aortic valves.

P990071/S003

10/21/02

Real-Time

Stockert 70 RF Generator with Software Version 1.033

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval to modify the Stockert 70 Generator so as to deliver up to 70 watts of power when used with the Navistar DS and Celsius DS catheters.  The Stockert 70 RF Generator is indicated for use in conjunction with a compatible catheter for catheter ablation procedures.

P000005/S005

10/23/02

180-Day

Carisolv Minimal Invasive Dental Caries Removal System

MediTeam Dental AB

Fridley, MN

55432

Approval for a modification to the formulation of Carisolv.

P000018/S021

10/25/02

Real-Time

β -Cath™ XL Delivery Catheter – 60 mm

Novoste Corp.

Norcross, GA

30093

Approval for the 60 mm β-Cath™ XL Delivery Catheter.

P000025/S005

10/29/02

Real-Time

Med-El COMBI 40+ Cochlear Implant System, Med-El Insertion Test Device (ITD)

Med-El Corporation

Durham, NC

27713

Approval for the Med-El Surgical Claw, working angle -45 º, as a modification of the Med-El COMBI 40+ Cochlear Implant System.  The device, as modified, will be marketed under the trade name Med-El Surgical Claw, working angle -45 º, and is indicated for use where there is planned access to the inner ear during surgery.

P000037/S002

10/11/02

180-Day

On-X® Conform-X® Aortic Prosthetic Heart Valve, Model ONXAC

Medical Carbon Research Institute (MCRI), LLC

Austin, TX

78754

Approval for a modified aortic sewing cuff as an extension to the line of available valves; the request applied to the aortic sizes 19, 21, 23, 25, and 27/29 mm.  The device, as modified, will be marketed under the trade name On-X® Conform-X® Aortic Prosthetic Heart Valve and will be given the model designation of Model ONXAC and is indicated for replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.

P000058/S001

10/4/02

180-Day

InFUSE™ Bone Graft/LT-Cage Lumbar Tapered Fusion Device

Medtronic Sofamor Danek

Memphis, TN

38132

Approval of the post-approval clinical study for the device.  The post-approval clinical study has been submitted to comply with the conditions of approval outlined in the July 2, 2002 approval order for P000058.

P010003/S002

10/08/02

180-Day

BioGlue Surgical Adhesive

CryoLife, Inc.

Kennesaw, GA

30144

Approval for a manufacturing site located at CryoLife, Inc., Kennesaw, Georgia.

P010012/S004

10/7/02

180-Day

Models H115 and H119 CONTAK CD 2 (CRT-D) Cardiac Resynchronization Therapy Defibrillator System

Guidant Corporation

St. Paul, MN

55112

Approval for the Models H115 and H119 CONTAK CD 2 Cardiac Resynchronization Therapy Defibrillator (CRT-D).  The CONTAK CD 2 CRT-D 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 ≥120 ms and remain symptomatic despite stable, optimal heart failure drug therapy.  Patients 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 hymodynamically 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.

P010025/S001

10/2/02

180-Day

Selenia™ Full Field Digital Mammography System

Hologic, Inc.

Bedford, MA

01730

Approval for an amorphous selenium digital receptor, a change in the name of the product to Selenia™ and the addition of a soft copy display for interpretation of screening and diagnostic mammograms.  The device, as modified, will be marketed under the trade name Selenia™ Full Field Digital Mammography System and is indicated for generating digital mammographic images that can be used for screening and diagnosis of breast cancer.  The Selenia™ Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammographic systems.  Mammographic images can be interpreted on either hard copy film or the Selenia™ soft copy review workstation.  Also, approval for the addition of the Lorad Facility, Danbury, Connecticut, as a manufacturing site for the Selenia™ Full Field Digital Mammography System.

P010030/S001

10/09/02

180-Day

LifeVest™ WCD® 3000 System

Lifecor, Inc.

Pittsburgh, PA

15238

Approval for modifications to the WCD® Monitor (P010030/S001) and Electrode Belt/Chest Garment System (P010030/S003).  The system, as modified, will be marketed under the trade name LifeVest™ WCD® 3000 System and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.

P010030/S003

10/09/02

180-Day

LifeVest™ WCD® 3000 System

Lifecor, Inc.

Pittsburgh, PA

15238

Approval for modifications to the WCD® Monitor (P010030/S001) and Electrode Belt/Chest Garment System (P010030/S003).  The system, as modified, will be marketed under the trade name LifeVest™ WCD® 3000 System and is indicated for adult patients who are at risk for sudden cardiac arrest and either are not candidates for or refuse an implantable defibrillator.

P010031/S001

10/25/02

180-Day

Medtronic InSync® Implantable Cardioverter Defibrillator Model 7272

Medtronic, Inc.

Minneapolis, MN

55432

Approval of the post-approval study for the device.

P010031/S002

10/23/02

Real-Time

Medtronic Model 7272 InSync ICD

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a change to the connector assembly of the Medtronic Model 7272 InSync® ICD.

P810046/S213

10/23/02

Coronary Dilatation Catheters

Guidant Corporation

Temecula, CA

92591

Change to a revised sampling group and a pyrogen sampling plan for coronary dilatation catheters.

P860019/S187

10/23/02

PTCA Catheters, NIR® Premounted Stent Delivery System, and Express/

Express2™ Coronary Stent System

Boston Scientific/Scimed, Inc.

Maple Grove, MN

55311

Change involving the reduction of BIOSLIDE™ curing time by increasing the allowed percent oxygen and level of UV exposure.

P900039/S012

10/10/02

Collagraft® Strip Bone Graft Matrix

NeuColl, Inc.

Campbell, CA

95008

Change in the definition of a sample item portion (SIP) from a Strip alone to a Strip plus inner packaging (inner tray, inner tray lid, lift tab, and tray retainer).  Only a single SIP may be sourced from each tray.

P900052/S011

10/3/02

PORT-A-CATH® Epidural and PORT-A-CATH® II Low Profile™ Epidural Systems

Dletec, Inc.

St. Paul, MN

55112

Change in the method of marking the product name and lot number on the portal reservoirs from engraving to laser marking.

P980001/S041

10/23/02

PTCA Catheters, NIR® Premounted Stent Delivery System, and Express/

Express2™ Coronary Stent System

Boston Scientific/Scimed, Inc.

Maple Grove, MN

55311

Change involving the reduction of BIOSLIDE™ curing time by increasing the allowed percent oxygen and level of UV exposure.

P000049/S005

10/23/02

CardioSEAL® Septal Occlusion System with

Qwik Load

NMT Medical, Inc.

Boston, MA

02210

Change in the manufacturing process of the device which involves the removal of the requirement for routine testing of anaerobic bacteria from NMT Product Bioburden Procedure.

P010018/S001

10/28/02

Viewpoint CK System (Keratoplast tip component)

Refractec

Irvine, CA

92618

Alternative/ equivalent UV curable adhesive to be used in the bonding process during manufacture of the keratoplast tip.

P010033/S001

10/24/02

QuantiFERON-TB

Cellestis, Ltd.

Victoria, Australia

3163

Change in the manufacturing of Microtiter plates from a semi-manual to an automated process.

P020009/S001

10/23/02

PTCA Catheters, NIR® Premounted Stent Delivery System, and Express/

Express2™ Coronary Stent System

Boston Scientific/Scimed, Inc.

Maple Grove, MN

55311

Change involving the reduction of BIOSLIDE™ curing time by increasing the allowed percent oxygen and level of UV exposure.