1/6/2000

McCue CUBAClinical Ultrasonic Bone Sonometry System with CUBA^plus+V4.2.0 Software

McCue Corporation, Inc.

Sarasota, FL 34242

Approval for the McCue CUBAClinical Ultrasonic Bone Sonometry System to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk. The CUBAClinical measures two parameters, Broadband Ultrasound Attenuation (BUA in dB/MHz) which is used for the clinical measurement and Velocity of Sound (VOS in m/s) which is used for QA purposes only. The BUA output is expressed both as an absolute value and, with reference to the embedded Normative Data, as a T-Score, Z-score, and the percent expected (age-matched).

1/20/2000

Omnisense Ultrasound Bone Sonometer

Sunlight Ultrasound Technologies, Ltd.

c/o Hogan & Hartson, Washington, DC 20004-1100

Approval for the Sunlight OmnisenseÔ (Omnisense) Ultrasound Bone Sonometer is a non-invasive device that is designed for the quantitative measurement of the velocity of ultrasound waves ("Speed of Sound" or "SOS in m/sec") propagating along the distal one-third of the radius bone. SOS provides a measure of skeletal fragility. The output is also expressed as a T-score and Z-score and can be used in conjunction with other clinical risk factors as an aid to the physician in diagnosis of osteoporosis and other medical conditions leading to reduced bone strength and, ultimately, in the determination of fracture risk. The SOS measured by Omnisense has a precision error low enough in comparison with the expected annual change in a patients’ 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).

1/28/2000

Senographe 2000D Full Field Digital Mammography System

GE Medical Systems

Milwaukee, WI 53201

Approval for the Senographe 2000D Full Field Digital Mammography System indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The device is intended to be used in the same clinical applications as traditional mammographic film-screen systems

PMA Supplemental Approvals

1/6/2000

Vitekâ 2 Gram Negative Susceptibility Test for Gentamicin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic gentamicin at concentrations of 4, 16, and 32 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System.

1/10/2000

Vitekâ 2 Gram Positive Susceptibility Test for Levofloxacin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic levofloxacin at concentrations of 0.25, 2 and 8 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System.

1/21/2000

Vitekâ 2 Gram Negative Susceptibility Test for Nitrofurantoin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic nitrofurantoin at concentrations of 16, 32 and 64 m g/ml to the VitekÒ 2 Gram Negative Susceptibility Test System.

1/24/2000

Vitekâ 2 Gram Positive Susceptibility Test for High-Level Gentamicin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic gentamicin at a concentration of 500 m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System.

1/31/2000

Vitekâ 2 Gram Positive Susceptibility Test for Norfloxacin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic norfloxacin at concentrations of 0.5, 1 and 4m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System.

1/31/2000

Vitekâ 2 Gram Positive Susceptibility Test for Gentamicin

bioMerieux, Inc.

Hazelwood, MO 63042-2320

Approval for the addition of the antibiotic gentamicin at concentrations of 8, 16, and 64m g/ml to the VitekÒ 2 Gram Positive Susceptibility Test System.

1/28/2000

Model 3304 Programmer Software

St. Jude Medical

Sylmar, CA 91342

Approval for the Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers. The device, as modified, will be marketed under the trade name Model 3304 Programmer Software for use with the Model 3500 and Model 3510 Programmers and is indicated for the programming and interrogation of implanted St. Jude pacemakers.

1/19/2000

Stylet Accessory Kit Models 6983 and 6985

Guidant Corporation

St. Paul, MN 55112-5798

Approval for the stylet accessory kit Models 6983 and 6985.

1/14/2000

UVARÒ XTSÔ Photopheresis System

THERAKOS

Exton, Pennsylvania 19341

Approval for a new material, Codan Polypropylene RE764F/Cawiton, to be used in the body of the drip chamber of the UVARÒ XTSÔ system’s disposable set.

1/31/2000

FluorPermÒ 92 (paflufocon A), FluoroPermÒ 60, Paragon HDSÒ , VISIONSÔ (paflufocon B0, FluoroPermÒ 151 (paflufocon D)

Paragon Vision Sciences

Mesa, AZ 85202-6619

Approval for wet shipping and up to 30 day storage of the referenced extended wear rigid gas permeable lenses in Alcon Wetting, Soaking, Conditioning and Disinfecting Solution ID 84392

1/28/2000

Model 3304 Programmer Software

St. Jude Medical

Sylmar, CA 91342

Approval for the Model 3304 Programmer Software for use with the Model 3500 and Model 2510 Programmers. The device, as modified, will be marketed under the trade name Model 3510 Programmers and is indicated for the programming and interrogation of implanted St. Jude pacemakers.

1/7/2000

BonnieÔ MonorailÒ PTCA Catheter

Boston Scientific SCIMED, Inc.

Maple Grove, MN 55311

Approval for minor labeling revisions to the box and pouch labels for the Bonnie PTCA Catheter.

1/28/2000

Model 3304 Programmer Software

St. Jude Medical

Sylmar, CA 91342

Approval for the Model 3304 Programmer Software for use with the Model 3500 and Model 2510 Programmers. The device, as modified, will be marketed under the trade name Model 3510 Programmers and is indicated for the programming and interrogation of implanted St. Jude pacemakers.

1/28/2000

PALMAZÔ Balloon Expandable Stent

Cordis Corporation

Miami, FL 33102-5700

Approval for additional models of the PALMAZÔ balloon expandable stent and the use of the OPTA LPÔ and Powerflex PlusÔ balloon catheters as delivery systems for the stents. The additional stent models include stents with an expansion range from 6-8 mm and lengths from 10-30mm. These devices are indicated for use following a technically successful but suboptimal iliac angioplasty procedure.

1/21/2000

Arrow Model 3000-16 and 3000-50 Constant Flow Implantable Drug Delivery Pumps with Bolus Safety Valve: addition of Lioreseal (Baclofen) delivery to labeling

Arrow International

Warpole, MA 02081

Approval for adding the Drug Lioreseal (Baclofen) to the list of drugs approved for use with the Model 3000-16 and Model 3000-50 Implantable Drug Delivery Pumps. Also, the labeling will clearly indicate that baclofen is stable in the pump reservoir for 44 days at 37° C.

1/28/2000

RotablatorÒ Rotational Angioplasty System

Boston Scientific Corp.

Redmond, WA 98052-3376

Approval for a labeling change to the console Instructions for Use.

1/28/2000

Vitesse-C OS Laser Angioplasty Catheters: Models 114-009, 117-016, and 120-009

Spectranetics Corp.

Colorado Springs, CO 80907

Approval for the Vitesse-C OS Laser Angioplasty Catheters: Models 114-009, 117-016, and 120-009.

1/18/2000

Matritech NMP22Ò Test Kit

Matritech, Inc.

Newton, MA 02160

Approval to use this device as an aid 1) in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off ³ 7.5 U/mL) in conjunction with and not in lieu of current standard diagnostic procedures, and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off>10U/mL).

1/11/2000

The Heart LaserÔ CO₂ TMR System

PLC Medical Systems, Inc.

Franklin, MA 02038

Approval for specific supplementary product labeling.

1/20/2000

SPLÒ Leads (Models SP01, SP02, SP03, and SP04)

St. Jude Medical

Sunnyvale, CA 94086-6527

Approval for minor modifications to SPLÒ Leads (Models SP01, SP02, SP03, and SP04)

1/13/2000

NeuroControl FreehandÒ System

NeruoControl Corporation

Valley View, OH 44125-6104

Approval for 1) replacing the MRI Warning in the Package Insert, Clinical Manual, and User Manual for the FreehandÒ System and replacing it with a Precaution implanted with the FreehandÒ System; 2) modifying the patient’s FreehandÒ System ID Card to include wording advising NeuroControl be contacted for information prior to MRI scanning; and 3) An "MRI Information Sheet" which provides detailed guidance for MRI scanning and will be provided upon request.

1/7/2000

ThinLine II Endocardial Pacing Lead Models 430-25, 430-35, and 432-35; ThinLine II EZ Pacing Lead Models 438-25 and 438-35; FINELINE II Pacing Lead Models 4452, 4453, 4454, 4455, 4477, and 4478; FINELINE II EZ Pacing Lead Models 4463, 4464, 4465, 4466, 4467 and 4468

Guidant Corporation

St. Paul, MN 55112-5798

Approval for the silicone and polyurethane ThinLine II and FINELINE II pacing leads. The devices, as modified, will be marketed under the trade names: ThinLine II Endocardial Pacing Lead Models 430-25, 430-35, and 432-35; ThinLine II EZ Pacing Lead Models 438-25 and 438-35; FINELINE II Pacing Lead Models 4452, 4453, 4454, 4455, 4477, and 4478; FINELINE II EZ Pacing Lead Models 4463, 4464, 4465, 4466, 4467 and 4468

1/21/2000

VENTAKÒ PRIZMÔ DR/VR AICD System, Models 1850, 1851, 1855 and 1856 with Model 2844 Software, Version 1.1

Guidant Corporation

St. Paul, MN 55112-5798

Approval for modifications to VENTAKÒ DR/VR AICD. The device, as modified, will be marketed under the trade name VENTAKÒ PRIZMÔ DR/VR AICD System, Models 1850, 1851, 1955 and 1856 with Model 2844 Software, Version 1.1 and the indication remains the same as in the original premarket approval application.

1/7/2000

LADARVisionÒ Excimer Laser System for Photorefractive Keratectomy (PRK)

Autonomous Technologies Corporation

Orlando, FL 32826

Approval to modify your current labeling by adding the following statement to the Warnings sections of the patients information booklet, the physician’s booklet, and the system operation manual clarifying the pupil size required to optimize the tracker performance: "A minimum of pre-operative pupillary dilation of 7 mm and a maximum dilation of 11 mm must be achieved and maintained in all patients throughout the refractive procedure to optimize tracker performance."

1/13/2000

Ancure Endovascular Grafting System for the treatment of abdominal aortic aneurysms

Guidant Corporation

Menlo Park, CA 94025

Approval for manufacturing changes under 21 CFR 814.39 (d).

1/7/2000

Ancure Endovascular Grafting System for the treatment of abdominal aortic aneurysms

Guildant, Cardiac and Vascular Surgery Group

Menlo Park, CA 94025

Approval for labeling changes under 21 CFR 814.39 (d).

1/27/2000

PepGen P-15

Morin & Krasny

c/o CeraMed Corp.

San Francisco, CA 94105-1635

Approval for a sterilization facility located at STERIS-Isomedix Services, 9120 South 150 East, Sandy, Utah.