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PMA Final Decisions Rendered for December 2003

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME
CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P800035/S011

12/8/03

180-Day

Cerasorb Dental

Curasan AG

Dkeinostheim, Germany

D-63801

Approval for design changes, a trade name change, and new manufacturing sites.  This approval also acknowledges that ownership has been transferred from Miter, Inc. to Curasan AG.  Cerasorb Dental will be manufactured at two new facilities located at Curasan AG, Germany and Willy Rusch AG, Germany.  The device, as modified, will be marketed under the trade name Cerasorb Dental and is indicated for defects after extirpation of dental alveolar cysts; repair of marginal and periapical periodontal alveolar bony pockets as well as bifurcations and trifurcations of the teeth; augmentation of the atrophied alveolar ridge; alveolar augmentation of mandibular and maxillary ridges; defects after apicoectomy; and filling bone defects after surgical resection of impacted teeth (without implantation).

P890003/S073

12/29/03

Real-Time

Medtronic Model 2490E CareLink Monitors and Model 2491 DDMA Software for Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490E CareLink Monitor and Model 2491 DDMA Software to allow their use with the Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices.  The CareLink System is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P900023/S039

12/23/03

Special

ABIOMED® AB5000™ Circulatory Support System

ABIOMED, Inc.

Danvers, MA

01923

Approval for an additional label in the form of a packaging sticker stating, “Only use threaded restraints with the AB5000 Ventricle.  Use of non-threaded cannula restraints may result in: 1) cannulae becoming disconnected from the Ventricle, and  2) thrombus formation.”

P910016/S013

12/17/03

180-Day

LCS Unicompartmental Knee System

Depuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for a manufacturing facility located at Depuy Ireland, Ltd., Cork, Ireland.

P910077/S040

12/17/03

180-Day

VENTAK PRx and MINI Implantable Cardioverter Defibrillators

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes specific to defibrillator implant testing criteria.

P910077/S043

12/24/03

Special

VENTAK Mini I, II and III

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes to update battery longevity information.

P920014/S022

12/2/03

Real-Time

Thoratec® HeartMate® XVE and VE Lest Ventricular Assist System (LVAS)

Thoratec Corporation

Woburn, MA

01888

Approval for a modified Stroke Volume Limiter design for the HeartMate XVE and SNAP-VE devices.

P920047/S021

12/31/03

180-Day

Blazer II, Blazer RPM, SteeroCath-A, Steero-Cath-T, and Polaris Cardiac Ablation Catheters

Boston Scientific Corporation

San Jose, CA

95134

Approval for a sterilization facility located at Cosmed of Rhode Island, Inc., Coventry, Rhode Island.

P930014/S013

12/24/03

Real-Time

Acrysof IOL Model SN60WF

Alcon Laboratories

Fort Worth, TX

76134

Approval for Model SN60WF.

P930021/S008

11/2/03

180-Day

Emdogain® Gel

Biora, Inc.

Chicago, IL

60610

Approval for the addition of the following indication for use:  “Endogain® Gel is indicated for use in coronally positioned flap procedures for the treatment of gingival recession defects”.  The device, with this additional indication for use, will be marketed under the trade name Endogain® Gel.

P930027/S006

12/31/03

Real-Time

IMMULITE® 2500 PSA and IMMUITE® 2500 Third Generation PSA Tests

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for the introduction of the IMMULITE® 2500 PSA and IMMUITE® 2500 Third Generation PSA tests for use on the IMMULITE® 2500 Automated Immunoassay Analyzer.  The devices, as modified, will be marketed under the trade name IMMULITE® 2500 PSA and IMMULITE® 2500 Third Generation PSA assays for the following indication:  “The IMMULITE® 2500 PSA and IMMUITE® 2500 Third Generation PSA Assays are for in vitro diagnostic use with the IMMULITE 2500 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.  Each assay is further indicated as an adjunctive test to aid in the management of prostate cancer patients.”

P930031/S018

12/11/03

180-Day

Wallstent Endoprosthesis with Unistep Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN55311

Approval for the addition of two manufacturing facilities located at Boston Scientific Corp., Quincy, Massachusetts and Boston Scientific European Distribution Center, Maastricht-Airport, The Netherlands.  These facilities will perform packaging and labeling operations for the Wallstent Endoprosthesis with the Unistep Plus Delivery System.

P940019/S016

12/11/03

180-Day

Wallstent Endoprosthesis with Unistep Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN55311

Approval for the addition of two manufacturing facilities located at Boston Scientific Corp., Quincy, Massachusetts and Boston Scientific European Distribution Center, Maastricht-Airport, The Netherlands.  These facilities will perform packaging and labeling operations for the Wallstent Endoprosthesis with the Unistep Plus Delivery System.

P950008/S006

12/22/03

Real-Time

SILIKON 1000™

Alcon Laboratories

Fort Worth, TX

76134

Approval for a change to the specification for the finished product viscosity range.

P950037/S033

12/17/03

180-Day

Home Monitoring

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for modifications to Home Monitoring that will allow physicians to receive the implant data via the Internet, email, fax or mobile phone.  Home Monitoring may be used with the following BIOTRONIK devices: Philos DR-T, Belos DR-T, Belos VR-T, and Cardiac Airbag-T.

P960004/S023

12/19/03

Special

FINELINE® II Pacing Leads

Guidant Corporation

St. Paul, MN

55112

Approval for the addition of a specification for the conductor-to-terminal pin weld strength.

P960007/S018

12/15/03

Special

TranCyte Human Fibroblast-Derived Temporary Skin Substitute

Smith & Nephew Wound Management

La Jolla, CA

92037

Approval for the addition of a Direct Culture-based procedure for mycoplasma detection before TranCyte marketing release.

P960009/S027

12/16/03

180-Day

Medtronic Kinetra™ Model 7428 Implantable Neurostimulation System

Medtronic Neurological

Minneapolis, MN

55432

Approval for the Medtronic Kinetra™ Model 7428 Implantable Neurostimulation System which includes the Model 7428 Kinetra™ Neurostimulator, Model 7436 Access Therapy Controller, Model 8840 N’Vision Programmer, Model 8870 Software Application Card, Model 7459 MemoryMod® Software Cartridge, and Model 3550-09 Accessory Kit.  These are revisions to the existing Medtronic Activa® Parkinson’s Control Therapy also known as the Activa® System.  The Medtronic Kinetra™ Model 7428 Implantable Neurostimulation System is only indicated for Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) as an adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson’s disease that are not adequately controlled with medication.  Additionally, this supplement also incorporates the latest Magnetic Resonance Imaging (MRI) labeling information with respect to the above systems.

P960040/S034

12/17/03

180-Day

VENTAK AV, PRIZM, VITALITY, VITALITY AVT Implantable Cardioverter

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes specific to defibrillator implant testing criteria.

P960040/S038

12/24/03

Special

VENTAK PRIZM Models 1850 and 1851

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes to update battery longevity information.

P960052/S007

12/1/03

Special

Dermabond® Topical Skin Adhesive

Closure Medical Corp.

Raleigh, NC

27616

Approval for a labeling change to modify a WARNING statement (6^th bullet) to read, “High viscosity DERMABOND adhesive should not be used in high skin tension areas or across areas of increased skin tension, such as knuckles, elbows, or knees, unless the joint will be immobilized during the skin healing period or unless skin tension has been removed by application of another wound closure device (e.g., sutures or skin staples) prior to the application of high viscosity DERMABOND adhesive.”

P960058/S032

12/16/03

Real-Time

HiResolution™ Bionic Ear System

Advanced Bionics Corporation

Sylmar, CA

91342

Approval for an optional accessory item that can be used with the Platinum Headpiece and Auria Headpiece.  This item, named Headpiece Spacer, is a passive piece of elastomer intended to be placed between the Headpiece inner surface and the patient’s scalp.  The device, as modified, will be marketed under the trade name HiResolution™ Bionic Ear System and is indicated for adults with post-lingual onset of severe-to-profound hearing loss and in children with profound hearing loss (12-months to 17 years, 11-months of age).

P970021/S009

12/22/03

180-Day

Thermachoice III Uterine Balloon Therapy System

Ethicon, Inc.

Somerville, NJ

08876

Approval for the removal of the Pressure Relief Valve (PRV).

P970021/S010

12/2/03

180-Day

ThermaChoice III Uterine Balloon Therapy System

Ethicon, Inc.

Somerville, NJ

08876

Approval for a sterilization facility located at Steris Corporation, Isomedix Services, El Paso, Texas.

P970031/S013

12/8/03

180-Day

Freestyle® Subcoronary Bioprosthesis, Modified Subcoronary Configuration, Model 995MS, size 29 mm

Medtronic Heart Valves

Santa Ana, CA

92705

Approval for the Freestyle Subcoronary Bioprosthesis, Modified Subcoronary Configuration, Model 995MS, size 29 mm.  The supplement requested approval of this size as an addition to the existing, approved (October 31, 2001, under supplement S010) product line of sizes 19, 21, 23, 25, and 27 mm.  The device is indicated for the replacement of malfunctioning native or prosthetic aortic valves.

P980003/S010

12/31/03

180-Day

Chilli Cooled Ablation System

Boston Scientific Corporation

San Jose, CA

95134

Approval for a sterilization facility located at Cosmed of Rhode Island, Inc., Coventry, Rhode Island.

P980016/S039

12/29/03

Real-Time

Medtronic Model 2490E CareLink Monitors and Model 2491 DDMA Software for Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490E CareLink Monitor and Model 2491 DDMA Software to allow their use with the Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices.  The CareLink System is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P980033/S008

12/11/03

180-Day

Wallstent Endoprosthesis with Unistep Plus Delivery System

Boston Scientific Corporation

Maple Grove, MN55311

Approval for the addition of two manufacturing facilities located at Boston Scientific Corp., Quincy, Massachusetts and Boston Scientific European Distribution Center, Maastricht-Airport, The Netherlands.  These facilities will perform packaging and labeling operations for the Wallstent Endoprosthesis with the Unistep Plus Delivery System.

P980035/S030

12/18/03

180-Day

EnPulse™ Implantable Pulse Generator, Models E1DR01, E1DR03, E1DR06, E1DR21, E2VDD01, E2SR01, E2SR03, E2SR06 and Model 9991 Application Software

Medtronic, Inc. Minneapolis, MN

55432

Approval for EnPulse™ Implantable Pulse Generator and Model 9991 Application Software.  The device, as modified, will be marketed under the trade name EnPulse™ IPG and is indicated as follows: EnPulse™ pacemakers are indicated for use in patients who are experiencing accepted conditions warranting chronic cardiac pacing which include: 

1) Symptomatic paroxysmal or permanent second or third-degree AV block. 

2) Symptomatic bilateral bundle branch block.

3) Symptomatic paroxysmal or transient sinus node dysfunctions with or without associated AV conduction disorders.

4) Bradycardia-tachycardia syndrome.

5) Vasovagal syndromes or hypersensitive carotid sinus syndromes.  EnPulse™ pacemakers are also indicated for use in patients who may benefit from rate responsive pacing to support cardiac output during varying levels of activity.  Using rate response modes may restore heart rate variability by improving cardiac output.  These devices are also indicated for use in patients who may benefit from maintenance of AV synchrony through the use of dual chamber modes and atrial tracking modes.  Dual chamber modes are specifically indicated for treatment of conduction disorders that require restoration of both rate and AV synchrony.  Dual chamber modes are indicated for use in patients who have experienced one or both of the following conditions: 

1) Various degrees of AV block  2) VVI intolerance (for example, pacemaker syndrome) in the presence of persistent sinus rhythm.  This device is also indicated for VDD pacing in patients who have adequate rates and one or both of the following conditions:  1) A requirement for ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when atrial contribution is needed for hemodynamic benefit or when pacemaker syndrome had existed or is anticipated.  2) A requirement for intermittent ventricular pacing despite a normal sinus rhythm and normal AV conduction.

P980040/S005

12/15/03

Real-Time

Sensor® Soft Acrylic Posterior Chamber Intraocular Lens

Advanced Medical Optics, Inc.

Santa Ana, CA

92705

Approval for changes to the acrylic button annealing cycle.

P990028/S007

12/4/03

180-Day

FocalSeal® - L Synthetic Absorbable Sealant

Genzyme Corporation

Cambridge, MA

02142

Approval for complaint return and investigation operations to be transferred from the Genzyme facility in Lexington, Massachusetts to the Genzyme facility in Farmingham, Massachusetts.

P990054/S006

12/31/03

180-Day

Chilli and Chilli RPM Cooled Ablation System

Boston Scientific Corporation

San Jose, CA

95134

Approval for a sterilization facility located at Cosmed of Rhode Island, Inc., Coventry, Rhode Island.

P000008/S006

12/5/03

180-Day

BioEnterics® Lap-Band® Adjustable Gastric Banding System

Inamed Corp.

Santa Barbara, CA

93111

Approval for an additional size (11.0 cm) for the Lap-Band® Adjustable Gastric Banding System.  The device, as modified, will be marketed under the trade name Vanguard Lap-Band.

P000011/S009

12/8/03

Real-Time

Phosphorylcholine (PC) Coated BiodivYsio Open Cell (OC) Stent Premounted on an Over-the-Wire (OTW) Delivery System

Abbott Laboratories

Redwood City, CA

94063

Approval for the addition of an 8 mm stent in diameters of 3.0, 3.5, and 4.0 mm for the BiodivYsio OC OTW System.

P000021/S003

12/30/03

Real-Time

Dimension® TPSA Flex® Reagent Cartridge

Dade Behring, Inc.
Newark, DE 19714

Approval of the Dimension® TPSA FLEX® Reagent Cartridge on the Dimension® RxL Max™ analyzer.  The device will be marketed under the same trade name and is indicated for:  The TPSA method for the Dimension® clinical chemistry system with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure total prostate specific antigen (PSA) in human serum and plasma:  1) as an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older.  Prostate biopsy is required for diagnosis of cancer.  2) as an aid in the management (monitoring) of prostate cancer patients.

P000036/S003

12/15/03

Special

Dermagraft Human Fibroblast-Derived Dermal Replacement

Smith & Nephew Wound Management

La Jolla, CA

92037

Approval for the addition of a Direct Culture-based procedure for mycoplasma detection before Dermagraft product release.

P000037/S003

12/16/03

Real-Time

On-X Prosthetic Heart Valve

Medical Carbon Research Institute, LLC

Austin, TX

78754

Approval for a change to the vent hole configuration of the package and related change to the vent cover sealer pattern.

P000043/S008

12/22/03

180-Day

TMx-2000™ BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval for TherMatrx, Inc., Northbrook, Illinois as an alternate manufacturing site for the Temperature Sensor and Temperature Reference Probe.

P000058/S004

12/1/03

180-Day

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

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the inclusion of additional fusion cage component designs for use with the InFUSE™ Bone Graft Component.  The following part numbers were not included as part of this request: 890226, 890229, 890243, 890246, 890249, 9012426 and 9012429;  the device, as modified, will be marketed under the following trade names:  InFUSE™ Bone Graft/LT-CAGE™ Lumbar Tapered Fusion Device; InFUSE™ Bone Graft/INTER FIX™ Threaded Fusion Device; and InFUSE™ Bone Graft/INTER FIX™ RP Threaded Fusion Device.  For purposes of clarity, the LT-CAGE™ Lumbar Tapered Fusion Device, INTER FIX™ Threaded Fusion Devcie, and INTER FIX™ RP Threaded Fusion Device components are collectively referred to as “Interbody Fusion Device” for the remainder of this approval order.  The device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from L4-S1.  DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, function deficit and/or neurological deficit and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level. The InFUSE™ Bone Graft/LT-CAGE™ devices are to be implanted via an anterior open or a laparoscopic approach.   The InFUSE™ Bone Graft/INTER FIX™ Threaded Fusion Device; and InFUSE™ Bone Graft/INTER FIX™ RP Threaded Fusion Device are to be implanted via an anterior open approach only.  Patients receiving the InFUSE™ Bone Graft/Interbody Fusion Device should have had at least six months of nonoperative treatment prior to treatment with the InFUSE™ Bone Graft/Interbody Fusion Device.

P010007/S002

12/31/03

Real-Time

IMMULITE® AFP and IMMULITE® 2000 AFP

Diagnostic Products Corporation

Los Angeles, CA

90045

Approval for use of the IMMULITE® 2000 AFT on the IMMULITE® 2500 Automated Analyzer.  The device, as modified, will be marketed under the trade name IMMULITE 2500 AFP and is indicated:  “For in vitro diagnostic use with the IMMULITE 2500 Analyzers for the quantitative measurement of alpha-fetoprotein (AFP) in either of two contexts: (1) serial measurements in human serum to aid in the management of patients with nonseminomatous testicular cancer; or (2) measurements in maternal serum and amniotic fluid during gestational weeks 15 through 20, used in conjunction with ultrasonography or amniography, to aid in detection of fetal open neural tube defects.”

P010012/S015

12/17/03

180-Day

CONTAK CD and RENEWAL Cardiac Resynchronization Therapy Defibrillators

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes specific to defibrillator implant testing criteria.

P010012/S019

12/24/03

Special

CONTAK CD 2 Model H115

Guidant Corporation

St. Paul, MN

55112

Approval for labeling changes to update battery longevity information.

P010013/S007

12/5/03

Special

NovaSure™ Impedance Controlled Endometrial Ablation System

Novacept, Inc.

Palo Alto, CA

94303

Approval for a change to a warning in the labeling regarding uterine perforations.

P010031/S011

12/29/03

Real-Time

Medtronic Model 2490E CareLink Monitors and Model 2491 DDMA Software for Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices

Medtronic, Inc.

Minneapolis, MN
55432

Approval for the Model 2490E CareLink Monitor and Model 2491 DDMA Software to allow their use with the Maximo DR/VR, Models 7278 & 7232 and InSync II Marquis, Model 7289 devices.  The CareLink System is indicated for use by a patient to interrogate their implanted device, and transfer the data to a private, secure server by use of a standard (analog) telephone connection.

P010049/S009

12/23/03

Real-Time

QuickSeal™ Control Femoral Arterial Closure System

Sub-Q, Inc.

San Clemente, CA

92673

Approval to reduce the minimum required access site depth from 3 centimeters to 2 centimeters in the Instructions for Use.

P020025/S002

12/31/03

180-Day

Blazer II XP Cardiac Ablation Catheter

Boston Scientific Corporation

San Jose, CA

95134

Approval for a sterilization facility located at Cosmed of Rhode Island, Inc., Coventry, Rhode Island.

P020035/S001

12/18/03

Real-Time

X-PRESS™ Trimmer - Accessory to the X-PRESS™ 6 French Vascular Closure System

X-SITE Medical, L.L.C.

Blue Bell, PA  19422

Approval for a new accessory that incorporates the knot pusher and suture cutter accessories into a single device.  This newly created accessory will be marketed under the trade name X-PRESS™ Trimmer, which allows the operator to push the clinch knot and cut the suture below the skin line following the use of the X-PRESS™ 6 French Vascular Closure System.

P810031/S025

12/12/03

Healon® Sodium Hyaluronate

Pfizer, Inc.

Kalamazoo, MI

49001

Installation of a new autoclave for the Healon® Sodium Hyaluronate.

P900033/S010

12/4/03

Dermal Regeneration Template

Integra LifeSciences Corporation

Plainsboro, NJ

08536

Adding an alternate material vendor for primary foil pouch packaging.

P910077/S042

12/19/03

Ventak Mini III, Mini IV

Guidant Corporation

St. Paul, MN

55112

Change in the sterilization release method from the use of biological indicators to parametric release.

P940031/S029

12/19/03

Merican, Discovery

Guidant Corporation

St. Paul, MN

55112

Change in the sterilization release method from the use of biological indicators to parametric release.

P960040/S037

12/19/03

Ventak AV /Prizm/Prizm 2, Vitality

Guidant Corporation

St. Paul, MN

55112

Change in the sterilization release method from the use of biological indicators to parametric release.

P970003/S052

12/23/03

VNS Therapy™ System

Cyberonics, Inc.

Houston, TX

77058

Change in the location of the performance of the environmental testing.

D970003/S026

12/19/03

Pulsar Max Discovery II, Insignia

Guidant Corporation

St. Paul, MN

55112

Change in the sterilization release method from the use of biological indicators to parametric release.

P000052/S022

12/18/03

GALILEO® III Intravascular Radiotherapy Systems

Guidant Corporation

Houston, TX

77054

Change in the manufacturing process for Guidant’s P-32 Source Wire by using an alternate needle coating process and material.

P010012/S018

12/19/03

Contak CD/CD2, Renewal

Guidant Corporation

St. Paul, MN

55112

Change in the sterilization release method from the use of biological indicators to parametric release.

P020009/S013

12/10/03

Express/ Express2™ Coronary Stent System

Boston Scientific, Cardiovascular

Maple Grove, MN

55311

Change to the manufacturing process involving the full automation of the stent finishing process (cleaning and electropolishing) for the stent component for the Express/ Express2™ Coronary Stent System.