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PMA Final Decisions Rendered for June 2001

6/1/01

Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory, and PreciControl HBsAg

Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for the Elecsys® HBsAg Immunoassay, Elecsys® HBsAg Confirmatory, and PreciControl HBsAg. The devices are indicated for: Elecsys® HBsAg Immunoassay is an immunoassay for the in vitro qualitative detection of hepatitis B surface antigen (HBsAg) in human serum and plasma (heparin, EDTA-K3, sodium citrate). Assay results in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B. In addition, this assay may be used to screen for hepatitis B infection in pregnant women to identify neonates who are at high risk of acquiring HBV during the perinatal period. The electrochemilumin-escence immunoassay "ECLIA" is intended for use on the Roche Elecsys 2010 Immunoassay System. Elecsys® HBsAg Confirmatory is an immunoassay for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen in human serum and plasma (heparin, EDTA-K3, sodium citrate) samples repeatedly reactive when tested with Elecsys 2010 HBsAg Immunoassay. PreciControl HBsAg is used for quality control of the Elecsys HBsAg Immunoassay on the Elecsys 2010 Immunoassay System when testing human serum. The performance of the PreciControl HBsAg has not been established with any other HBsAg assay.

6/27/01

Carisolv™ Non-Invasive Dental Caries Removal System

MediTeam AB

Savedalen, Sweden

Approval for the Carisolv™ Non-Invasive Dental Caries Removal System. The device is intended for the chemo-mechanical softening and removal of dentin caries when used in conjunction with a dental handpiece.

6/5/01

LAP-BAND® Adjustable Gastric Banding (LAGB®) System

BioEnterics Corporation

Carpinteria, CA

93013

Approval for the LAP-BAND® Adjustable Gastric Banding (LAGB®) System. The device is indicated for use in weight reduction for severely obese patients with a Body Mass Index (BMI) of at least 40 or a BMI of at least 35 with one or more severe comorbid conditions, or those who are 100 lbs. or more over their estimated ideal weight according to the 1983 Metropolitan Life Insurance Tables (use the midpoint for medium frame). It is indicated for use only in severely obese adult patients who have failed more conservative weight-reduction alternatives, such as supervised diet, exercise and behavior modification programs. Patients who elect to have this surgery must make the commitment to accept significant changes in their eating habits for the rest of their lives.

6/29/01

TMx-2000™ BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval for the TMx-2000™ BPH Thermotherapy System. The device is indicated as a non-surgical device for the treatment of symptomatic benign prostatic hyperplasia (BPH) in men who have a minimum prostatic urethra length of 30 mm and a total prostate volume between 30 and 100 cc.

6/14/01

AMS Sphincter 800™ Urinary Prosthesis

American Medical Systems

Minnetonka, MN

55343

Approval for the AMS

Sphincter 800™ Urinary Prosthesis. The device is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery.

Vitek® Gram Positive Susceptibility (GPS) Card for Gatifloxacin

bioMérieux, Inc.

Hazelwood, MO

63042

Approval for the addition of the antibiotic gatifloxacin at concentrations of 1, 4, and 8 mcg/ml to the Vitek®Gram Positive Susceptibility Panel. The device will be marketed under the trade name Vitek® Gram Positive Susceptibility (GPS) Card for Gatifloxacin, and is indicated for use in Vitek® Gram Positive Susceptibility Test Cards for the susceptibility testing of staphylococcus aureus and staphylococcus saprophyticus isolates to gatifloxacin in the range of ≤ 0.5 to ≥ 8 mcg/ml.

180-Day

Vitek® Gram Positive Susceptibility (GPS) Card for Quinupristin/

Dalfopristin

bioMérieux, Inc.

Hazelwood, MO

63042

Approval for the addition of the antibiotic quinupristin/

dalfopristin at concentrations of 0.75, 1.5, and 3 mcg/ml to the Vitek® Gram Positive Susceptibility Panel. The device will be marketed under the trade name Vitek® Gram Positive Susceptibility (GPS) Card for Quinupristin/

Dalfopristin, and is indicated for use in Vitek® Gram Positive Susceptibility Test Cards for the susceptibility testing of methicillin-susceptible Staphylococcus aureus, vancomycin-resistant Enterococcus faecium, Staphylococcus epidermidis, and Streptococcus agalactiae isolate to quinupristin/

dalfopristin in the range of ≤ .5 to ≥ 4 mcg/ml.

180-Day

Vitek® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Trimethoprim/

Sulfamethoxazole

bioMérieux, Inc.

Hazelwood, MO

63042

Approval for changes in the antibiotic design specification for the antibiotic trimethoprim/

sulfamethoxazole at concentrations of 2/38, 8/152, 16/304, and 32/608 µg/ml to the vitek® 2 Gram Positive AST Panel for Streptococcus pneumoniae: Trimethoprim/

Sulfamethoxazole. The device, as modified, will be marketed under the trade name Vitek® 2 and is indicated for use in Vitek® 2 Gram Positive AST Panel for Streptococcus pneumoniae for the susceptibility testing of Streptococcus pneumoniae isolates to trimethoprim/

sulfamethoxazole in the range of ≤ .5/9.5 to ≥ 16/304 µg/ml.

Real-Time

R2L Rapid Exchange Balloon Dilatation Catheter with Extended Pressure Range and D2L Over-the-Wire Balloon Dilatation Catheter with Extended Pressure Range

Medtronic AVE, Inc.

Santa Rosa, CA

95403

Approval for the R2L Rapid

Exchange and D2L Over-the-Wire Balloon Dilatation Catheters with Extended Pressure Range. The devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

Real-Time

Coronary Dilatation Catheter: Alternate white foil marker material

Guidant Corporation

Temecula, CA

92589

Approval for modifications of white foil markers in the POWERSAIL™, HIGHSAIL™, CROSSSAIL™, OPENSAIL™, and ACS ESPRIT PTCA catheters.

Real-Time

LCS Total Knee System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the addition of revision tibial bearings, porous-coated revision femoral components, and femoral and tibial sleeve components. Also, approval for modifications to the current textured revision femoral components and current revision femoral and tibial augment components. The devices, as modified, will be marketed as LCS Complete components.

Special

Medtronic Spinal Cord Stimulation System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with a Medtronic Spinal Cord Stimulation System.

Real-Time

Helistat®/Helitene® Absorbable Collagen Hemostatic Agents

Integra LifeSciences Corporation.

Plainsboro, NJ

08536

Approval for the removal of the neurological exclusion from the Indications Statement.

Real-Time

CapSure SP Novus Lead Model 5594

Medtronic, Inc.

Shoreview, MN

55126

Approval for Cap

Sure SP Novus Lead Model 5594. The device is indicated for pacing and sensing in the atrium. The lead has applications where implantable atrial single-chamber or dual-chamber pacing systems are indicated.

Real-Time

SynchroMed® Implantable Infusion Pump System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for three new pump connector designs and a change in the Model 8709 Catheter Kit contents: 1) New Model 8575 40˚ pump connector for the Model 8709 intrathecal catheter. 2) New Model 8577 90˚ pump connector for the Model 8709 intrathecal catheter. 3) New Model 8576 90˚ pump connector for use with the Model 8700A and Model 8700V vascular catheters. 4) New Model 8709 Catheter Kits will replace the current catheters with the 40˚ model 8575 pump connector for SynchroMed pumps with a CAP (Catheter Access Port), or a Model 8577 90˚ pump connector for a SynchroMed pump without a CAP.

135-Day

NC Maxxum PTCA Catheter

Boston Scientific/ SCIMED, Inc.

Maple Grove, MN

55311

Approval for an improved process which will allow use of n-heptane for cleaning balloons and catheter shaft components prior to bonding.

180-Day

Thoratec Ventricular Assist Device

Thoratec Corporation

Pleasanton, CA

94588

Approval for the addition of the TLC-II portable pneumatic driver to the Thoratec paracorporeal Ventricular Assist Device System. The TLC-II portable pneumatic driver is intended to be interchangeable with the Dual Drive Console in the Thoratec Paracorporeal Ventricular Device System for either bridge to transplant patients or for postcardiotomy recovery patients who are unable to be weaned from cardiopulmonary bypass. The TLC-II portable pneumatic driver is intended for use either in the hospital or in a medically monitored residence facility. In addition, the TLC-II portable pneumatic driver can be used to allow suitably qualified patients to take off-site excursions within a two-hour travel radius of the hospital in the company of a trained caregiver.

Vitesse Point 9mm X80 Percutaneous Coronary Angioplasty Catheter, Model 110-004, and the Extreme Point 9mm X80 Percutaneous Coronary Angioplasty Catheter, Model 110-002

Spectranetics Corporation

Colorado Springs, CO

80907

Vitesse Point 9mm X80 Percutaneous Coronary Angioplasty Catheter, Model 110-004, and the Extreme Point 9mm X80 Percutaneous Coronary Angioplasty Catheter, Model 110-002: 1) a change in the lasting time from 5 seconds on and 10 seconds off to 10 seconds on and 5 seconds off; 2) a change in the fluence and repetition rate from 30-60 Fluence and 25-40 Hz to 30-80 Fluence and 25-80 Hz; 3) a labeling change from "laser advancement of approximately 1 mm per second" to "maintain constant catheter tip contact with the lesion by applying mild forward pressure to the shaft of the catheter"; and 4) a change in the pin code on the coupler so that the catheters instruct the laser system to allow increased lasing parameters.

Real-Time

Photon™ Micro (μ) DR/VR Models V-232/V-194 Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software, v2.3

St. Jude Medical

Sunnyvale, Ca

94086

Approval for Photon™ Micro (μ) DR/VR Models V-232/V-194 Implantable Cardioverter Defibrillator System with Model 3307 Programmer Software, v2.3. The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

180-Day

Model 6996 SQ Lead System and 6996T Tunneling Tool

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 6996 SQ Lead System and the 6996T Tunneling Tool. The Model 6996 SQ Lead System is for single, long-term subcutaneous use and is intended for use in patients in which implantable cardioverter defibrillators (ICD) are indicated. The lead is intended for use if a standard ICD system with one or two transvenous leads has not been efficacious in providing acceptable DFT measurements. The Model 6996 SQ lead is intended for use only with the following systems: a Medtronic ICD featuring a connector block with at least two DF-1 connector ports; and a Medtronic right ventricular lead for defibrillating/pacing/sensing. In addition, a third defibrillation lead, such as any Medtronic SVC lead, may be used with a lead adaptor.

Real-Time

Model 6726 DF-1 Y-Adaptor/Extender Kit

Medtronic, Inc.

Minneapolis, MN

55432

Approval for Model 6726 DF-1 Y-Adaptor/Extender Kit. The device is indicated to adapt two DF-1 lead connectors to a single DF-1 compatible connector port and/or will extend the length of a DF-1 lead connector. The Model 6726 has application for patients in which ICD systems are indicated.

180-Day

UroLume® Endoprosthesis

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a 1.5 cm stent length, a modification of the benign prostatic hypertrophy (BPH) indication, and correction of delivery tool labeling. The device, as modified, will be marketed under the trade name UroLume® Endoprosthesis. The BPH indication of the UroLume® Endoprosthesis will be modified as follows: The device is intended to relieve prostatic obstruction secondary to BPH in men at least 60 years of age, or men under 60 years of age who are poor surgical candidates, an whose prostates are at least 2.0 cm in length.

Panel

Immulite® PSA, Immulite® Third Generation PSA, Immulite® 2000 PSA, Immulite® 2000 Third Generation PSA

Diagnostic Products Corporation

Los Angeles, CA

90045

Immulite® PSA, Immulite® Third Generation PSA, Immulite® 2000 PSA, and Immulite® 2000 Third Generation PSA. Immulite® PSA is indicated for in vitro diagnostic use with the Immulite® Analyzer for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Immulite® Third Generation PSA is indicated for in vitro diagnostic use with the Immulite® Analyzer for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Immulite® 2000 PSA is indicated for in vitro diagnostic use with the Immulite® 2000 Analyzer for the Quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Immulite® 2000 Third Generation PSA is indicated for in vitro diagnostic use with the Immulite® 2000 Analyzer for the quantitative measurement of prostate-specific antigen (PSA) in human serum, as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years of older.

180-Day

CELSIUS™ Diagnostic/Ablation Deflectable Tip Catheter

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for changes in the screwing mechanism of the Redel connector and the vent hole placement in the CELSIUS™ catheter.

Real-Time

CELCIUS™ II Bidirectional Deflecting Diagnostic/Ablation Catheter, Models D-1213, D-1219

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for the bidirectional catheter tip to be modified from a dual lumen to a quad lumen.

180-Day

CELSIUS® and CELSIUS II® Diagnostic/Ablation Deflectable Tip Catheters and Temperature Cables

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for an alternate manufacturing site located at Biosense Webster, Inc., Chihuahua, Mexico.

Special

Medtronic Activa® Tremor Control System

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with a Medtronic Activa® Tremor Control System.

180-Day

LiveWire™ TC Compass Catheter

St. Jude Medical

Minnetonka, MN

55345

Approval for 1 (one) year shelf-life, the incorporation of additional electrodes for stimulation and mapping (10 electrodes total), and other minor device modifications. The device, as modified, will be marketed under the trade name LiveWire™ TC Compass Catheter and is indicated for use for cardiac electro-physiological. Mapping and for use with a compatible RF generator for: interruption of accessory atrioventricular (AV) conduction pathways associated with tachycardia; the treatment of AV nodal block re-entrant tachycardia (AVNRT); or creation of completion AV nodal block in patients with difficult to control ventricular to an atrial arrhythmia.

Real-Time

Model 2725 VENTAK® PRIZM™ Diagnostic/

Restoration Tool Version 1.5

Guidant Corporation

St. Paul, MN

55112

Approval for Model 2725 VENTAK® PRIZM™ Diagnostic/

Restoration Tool Version 1.5. The device is indicated to diagnose and restore to factory normal settings VENTAK PRIZM/PRIZM HE devices that have been affected by a specific memory interaction that results in

Safety Mode.

180-Day

VENTAK PRIZM DR/VR and VENTAK PRIZM DR/VR HE ACID Systems

Guidant Corporation

St. Paul, MN

55112

Approval for an alternate manufacturing and sterilization facility located at Guidant Ireland, Clonmel Tipperary, Ireland and alternate sterilization facilities located at Isotron Ireland Ltd., Offaly, Ireland and Guidant, St. Paul, Minnesota.

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for labeling changes. The changes are intended to: 1) add a warning that recommends that physicians use care when treating patients with pre-existing obstructive sleep apnea (OSA), and 2) add and strengthen precautions regarding: a) electrosurgery, b) therapeutic ultrasound, c) exposure to environments that are protected by a warning notice preventing entry by patients with an implanted pacemaker, and d) application of other therapies involving electric current, such as TENS devices.

Real-Time

NeuroCybernetic Prosthesis (NCP) System

Cyberonics, Inc.

Houston, TX

77058

Approval for the Model 101 In-Line Pulse Generator (Version 2.0), Model 301 In-Line Bipolar Leads (Version 1.0), Model 402 In-Line Tunneling Tool (Version 1.0) and labeling changes.

Special

Medtronic InterStim® Therapy for Urinary Control

Medtronic, Inc.

Minneapolis, MN

55421

Approval for a change to the labeling to add a contraindication regarding the use of diathermy on patients implanted with a Medtronic InterStim®System.

Real-Time

Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Approval to revise the labeling to 1) add prior pelvic radiation as a contraindication; and 2) update the list of potential adverse events to include the risk of rectal fistula.

180-Day

AMS 700 Series Product Line Inflatable Penile Prostheses

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for revision of the labeling to include updated 5-year estimates of the rates of surgical revision (calculated from the Patient Information Form database).

Real-Time

ACS Multi-Link RX and OTW Pixel™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95052

Approval for the ACS Multi-Link RX and OTW Pixel™ Coronary Stent Systems. The devices are indicated for improving coronary lumen diameter in the following: Patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length <25 mm) with reference diameters from 2.0 to 2.5 mm. Long term outcome for this permanent implant is unknown at present.

Real-Time

ACS Multi-Link RX and OTW Duet™ Coronary Stent Systems – Revive Registry

Guidant Corporation

Santa Clara, CA

95052

Approval for the addition of a new indication for the ACS Multi-Link RX and OTW Duet™, Tristar™, Ultra™ Tetra™ Coronary Stent Systems and ACS Multi-Link® stent and the Four Delivery Systems. The new additional indication for these devices is for use in patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with a reference vessel diameter of 3.0 mm to 4.0 mm.

Real-Time

Multi-Link™ Family of Coronary Stent Systems

Guidant Corporation

Temecula, CA

92591

Approval for a replacement white foil marker material on the following Multi-Link™ family of coronary stent systems: Multi-Link Tetra™, Multi-Link Ultra™, Multi-Link Penta™ and Multi-Link Pixel™ (currently under review).

180-Day

CIBA Vision Posterior Chamber Intraocular Lens Models 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, and 0840Z

Ophthalmics Innovations International, Inc.

Ontario, CA

91761

Approval for Ophthalmic Innovations International, Inc. to private-label its PMA-approved posterior-chamber intraocular lenses for distribution in the United States by CIBA Vision Corporation. The devices as modified will be marketed under the trade-names, CIBA Vision Intraocular Lens Models 0420F, 0455F, 0440U, 0840U, 0430M, 0840Z2, and 0840Z, and are indicated for the visual correction of aphakia in persons 60 years of age or older, who are undergoing extracapsular extraction and primary lens implantation.

Real-Time

Programmer Application Software ELAVIEW (Version 1.04UG1)

ELA Medical, LLC

Plymouth, MN

55441

Approval for Programmer Application Software ELAVIEW (Version 1.04UG1)

180-Day

Omnisense 7000S Ultrasound Bone Sonometer

Sunlight Medical Ltd.

Rehovot, Isreal

76100

Approval for the addition of two new probes for use on two additional skeletal sites, the proximal third phalanx and the fifth metatarsal. The device, as modified, is indicated as follows: "A noninvasive device that is designed for the quantitative measurement of the signal velocity of ultrasonic waves ("Speed of Sound" or "SOS" in m/sec) propagating at multiple skeletal sites (i.e., the distal one-third of the radius, the proximal third phalanx, and the fifth metatarsal). SOS provides an estimate of skeletal fragility. The output is also expressed as a T-score and a Z-score, and can be used in conjunction with other clinical risk factors as an aid to the physician in the diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately , in the determination of fracture risk. Multiple skeletal site testing provides clinicians with alternatives if one site is not accessible and with additional skeletal information (i.e., from bones with different combinations of cortical and cancellous material and from weight bearing and non-weight bearing sites) that assists in diagnosing osteoporosis and risk fracture. The SOS measurement by Omnisense has a precision error low enough in comparison with the expected annual change in a patient’s measurement to make it suitable for monitoring bone changes which occur in the early years following menopause (i.e., age range approximately 50-65 years)."

Special

Vascular Solutions Duett™ Sealing Device

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for labeling changes in the instructions for use that add and strengthen the precautions and instructions.

180-Day

ATS Open Pivot Bileaflet Heart Valve

ATS Medical , Inc.

Minneapolis, MN

55447

Approval for a shelf life extension from 3 years to 5 years.

180-Day

Medtronic Mosaic® Porcine Bioprostheses, Model 305 (Aortic) and Model 310 (Mitral)

Medtronic Heart Valves

Santa Ana, CA

92705

Approval for the Post-Approval Study Protocol for the Medtronic Mosaic Porcine Bioprostheses, Model 305 (Aortic) and Model 310 (Mitral).

180-Day

High Profile Round Saline-Filled Breast Implant, Style 3000

Mentor Corporation

Santa Barbara, CA

93111

Approval for the High Profile Round Saline-Filled Breast Implant, Style 3000.

Real-Time

Novoste™ 40 mm Beta-Cath™ System

Novoste Corporation

Norcross, GA

30093

Approval for the Novoste™ 40 mm Beta-Cate™ System. The Novoste™ 40 mm Beta-Cath™ System is intended 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) in reference vessel diameter ranging from 2.7 to 4.0 mm.

180-Day

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

Medtronic AVE, Inc,

Santa Rosa, CA

95403

Approval for the updated labeling for the BeStent™ 2 with Discrete Technology™ Rapid Exchange and Over-the-Wire Coronary Stent Delivery Systems.

Real-Time

Cytosol Ophthalmics, Inc. Shellgel™ Sodium Hyaluronate

Anika Therapeutics, Inc.

Woburn, MA

01801

Approval for a private distributor agreement with Cytosol Ophthalmics, Inc. The device will be marketed under the trade name Shellgel™ Sodium Hyaluronate.

6/18/01

Avitene® Microfibrillar Collagen Hemostat (MCH) Non-Woven Web

Davol, Inc.

Cranston, RI

02920

Elimination of certain in process or final device tests performed on Avitene® Collagen Hemostasis (MCH) Products. This will eliminate test redundancy, waste and/or provide a more efficient utilization of test samples selected during the processing of Avitene.

6/21/01

Bonnie and Bypass Speedy PTCA Catheters

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the manufacturing process of the manifold component of the Bonnie and Bypass Speedy PTCA Catheters

6/7/01

NIR® Premounted Stent Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Change in the acceptance criteria for an in-process inspection step for the balloon component used in the manufacture of the NIR® Premounted Stent Systems.

6/7/01

ANCURE® Endograft® System

Guidant Corporation

Menlo Park, CA

94025

Changes to improve the deburring process for the two slot areas of the small hypotube.

6/18/01

Vitros Immunodiagnostic Products Anti-HBsAg Reagent Pack, Calibrators, and Confirmatory Kit

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Change to the acceptance criteria applied to the test for human plasma used as a raw material in the formulation of Assay reagent, a component of the Vitros HBsAg Confirmatory Kit.