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PMA Final Decisions Rendered for August 2002

NONE

P790002/S022

8/13/02

180-Day

EBI Bone Healing System™ - Model 2001

EBI, L.P.

Parsippany, NJ

07054

Approval for various hardware and software changes.

P830045/S082

8/13/02

Real-Time

Model 3307, v4.0a Programming Software and Model 3160 ECG Adapter Cable

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Model 3307, v4.0a Programming Software and the Model 3160 ECG Adapter Cable.

P830063/S002

8/28/02

180-Day

GAMBRO PRISMA TPE 2000 Set with Plasmafilter PF2000N

GAMBRO Renal Products

Lakewood, CO

80215

Approval for modifications to the requirements of the post-market study for the device.

P880086/S089

8/13/02

Real-Time

Model 3307, v4.0a Programming Software and Model 3160 ECG Adapter Cable

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Model 3307, v4.0a Programming Software and the Model 3160 ECG Adapter Cable.

P900043/S035

8/2/02

180-Day

Hepacoat™ on BX Sonic Balloon-Expandable Stent OTW Delivery System

Cordis Corporation

Miami, FL

33102

Approval for a modification of the indications for the Hepacoat™ on BX Sonic Balloon-Expandable Stent OTW Delivery System. The device, as modified, is indicated for improving coronary luminal diameter in the following:

1. for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (≤30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm involving direct stenting or predilatation; and
2. for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (≤30 mm in length) with reference diameters in the range of 2.25 mm to 4.0 mm. the 2.25 mm, 2.5 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions.

P900043/S036

8/22/02

180-Day

BX Velocity™ Stent with Raptor OTW Delivery System, BX Velocity™ Stent on RaptorRail RX Delivery System

Cordis Corporation

Warren, NJ

07059

Approval to amend the labeling (Instructions for Use) for the devices.

P900043/S037

8/22/02

180-Day

BX Velocity™ with Hepacoat on Raptor Stent System, BX Velocity™ Stent with Hepacoat on RaptorRail Delivery System (RX)

Cordis Corporation

Warren, NJ

07059

Approval to amend the labeling (Instructions for Use) for the devices.

P900043/S038

8/2/02

180-Day

Approval for a modification of the indications for the BX Sonic Balloon-Expandable Stent OTW Delivery System. The device, as modified, is indicated for improving coronary luminal diameter in the following:

1. for treatment of patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions (<30 mm in length) in native coronary arteries with reference diameters ranging from 3.0 mm to 5.0 mm involving direct stenting or predilatation; and
2. for treatment of abrupt or threatened vessel closure in patients with failed interventional therapy in lesions (<30 mm in length) with reference diameters in the range of 2.25 mm to 4.0 mm. the 2.25 mm, 2.5 mm, and 2.75 mm diameters are solely indicated for use in patients with abrupt or threatened closure, and the 4.5 and 5.0 mm diameters are indicated solely for use in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions

P900043/S041

8/22/02

Special

BX Velocity Stent with Hepacoat on Raptor OTW, RaptorRail RX, and Sonic OTW Delivery Systems

Cordis Corporation

Warren, NJ

07059

Approval for a change to the "Used By" dating on the devices.

P910023/S062

8/13/02

Real-Time

Model 3307, v4.0a Programming Software and Model 3160 ECG Adapter Cable

St. Jude Medical, Inc.

Sylmar, CA

91342

Approval for the Model 3307, v4.0a Programming Software and the Model 3160 ECG Adapter Cable.

P920004/S018

8/13/02

180-Day

VasoSeal® Elite VHD/ES Device

Datascope Corporation

Mah Wah, NJ

07430

Approval for the use of a single sponge collagen plug. The device, as modified, will be marketed under the trade names VasoSeal® Elite VHD or ES Device and is indicated for: "…sealing the femoral arterial puncture site in patients who have undergone diagnostic and interventional catheterization procedures using an 8 French or smaller procedural sheath and using a retrograde approach. The VasoSeal® Elite VHD/ES Device reduces time to hemostasis, and ambulation in patients who have undergone diagnostic and interventional catheterization procedures. In addition, the VasoSeal® Elite VHD/ES Device reduces time to discharge in diagnostic patients receiving 5-6 French procedural sheaths. VasoSeal® Elite VHD/ES Device reduces time to hemostasis in interventional, patients, when immediate sheath removal is desired." The VasoSeal® Elite VHD Device indications include the statement: "However, early ambulation in these patients has not been determined."

P930016/S015

8/7/02

Real-Time

VISX STAR S4™ Excimer Laser System

VISX, Inc.

Santa Clara, CA

95051

Approval for the addition of an auto-centering function to the VISX STAR S4™ Active Trak Eye Tracking System that includes Minor design and labeling changes.

P960043/S041

8/21/02

180-Day

Perclose® A-T (auto tie) Suture Mediated Closure (SMC) Device

Abbott Vascular Devices

Redwood City, CA

94063

Approval for a device name change, company name change, and labeling changes. The device, as modified, will be marketed under the trade name Perclose® A-T (auto tie) Suture Mediated Closure (SMC) Device and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 6 Fr. Sheaths. The Perclose A-T 6 Fr. SMC Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic or interventional catheterization procedures without complicating clinical conditions.

P970008/S019

8/1/02

180-Day

Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Approval for modification of the Targis™ System labeling regarding the treatment of patients with implanted active devices (including pacemakers and defibrillators).

D970012/S013

8/29/02

Real-Time

AMS 700 Series Product Line and Ambicor® Inflatable Penile Prostheses

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for changes to the embedded flash specifications of molded components of the AMS 700 Series Product Line and Ambicor® Inflatable Penile Prostheses.

P970015/S020

8/12/02

180-Day

LT-CAGE™ Tapered Fusion Device

Sofamor Danek USA

Memphis, TN

38132

Approval for a revised laparoscopic surgical technique for implantation of the LT-CAGE™. The device remains marketed under the trade name LT-CAGE™ Tapered Fusion Device and is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level form L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. LT-CAGE™ implants are to be used with autogenous bone graft and implanted via a laparoscopic or an open anterior approach. Patients receiving the LT-CAGE™ Lumbar Tapered Fusion Device should have had at least six months of nonoperative treatment prior treatment with the LT-CAG™E.

Approval for the addition of a new indication. The ACS MULTI-LINK devices are indicated for the following (see Individualization of Treatment):

1. Improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic native coronary artery lesions length <= 25 mm with a reference vessel diameter of 3.0 mm to 4.0 mm.
2. Improving coronary luminal diameter 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.
3. Restoring coronary flow in patients experiencing acute myocardial infarction, as confirmed by ST segment elevation or angiographic findings, who present within 12 hours of symptom onset with native coronary artery lesions of length <= 35 mm with a reference vessel diameter of 2.5 mm to 4.0 mm.
4. Treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions length <= 35 mm with a reference vessel diameter of 2.5 mm to 4.0 mm. Long-term outcome (beyond 6 months) for this permanent implant is unknown at present.
   

P970042/S002

8/20/02

180-Day

Medstone STS™ Lithotripter for the Treatment of Symptomatic, Solitary, Radiolucent, Non-Calcified Gallstones

Medstone International, Inc.

Aliso Viejo, CA

92656

Approval for

1. the use of two generic ursodiols, one manufactured by Amide Pharmaceutical and one by Teva Pharmaceutical, in addition to Actigall®;
2. a change in the post-approval study’s Medical Monitor to Joan L. Drucker M.D., R.S.I.; and
3. several minor clarifications, corrections and editorial changes to the post-approval study protocol. The device, as modified, will be marketed under the same trade name, Medstone STS™ lithotripter, and is indicated for the treatment of symptomatic, solitary, radiolucent, non-calcified gallstones (between 4 and 20 mm in maximum diameter) in adults patients for whom surgical removal of the gallbladder is medically contraindicated and in symptomatic high-risk patients who have actively refused surgery.

Combination therapy consists of

1. administration of Novartis Pharmaceutical Actigall®, or Amide Pharmaceutical Ursodiol, or Teva Pharmaceutical Ursodiol (8-10 mg/kg/day) for at least two weeks pre-lithotripsy,
2. lithotripsy treatments of up to 2000 24 kV shocks, and
3. continued administration of ursodiol until a stone-free state is achieved.

P980023/S010

8/30/02

Real-Time

ATA software cartridge (SWM 1000 I-KTB.0.U)

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for modifications to the PCMCIA software cartridge including an increase in memory. The device, as modified, will be marketed under the trade name ATA software cartridge (SWM 1000 I-KTB.0.U) and is intended to allow interrogation and programming of Biotronik ICD’s and pacemakers.

P990026/S008

8/26/02

Panel

GlucoWatch G2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for the GlucoWatch G2 Biographer, which expands the indications for use to include children/adolescents (age 7 to 17) to the currently approved indications for use. This device is now indicated for the following: 1) The Gluco Watch G2 Biographer is a glucose monitoring device indicated for detecting trends and tracking patterns in glucose levels in adults (age 18 and older) and children/adolescents (age 7 to 17) with diabetes. This device is intended for use by patients at home and in health care facilities. The device is for prescription use only. 2) the GlucoWatch G2 Biographer is indicated for use as an adjunctive device to supplement, not replace, information obtained from standard home glucose monitoring devices. 3) 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 minimized these excursions. Interpretation of Biographer results should be based on the trends and patterns seen with several sequential readings over time.

P990026/S014

8/23/02

Real-Time

GlucoWatch G2 Biographer

Cygnus, Inc.

Redwood City, CA

94063

Approval for extension of the shelf life of the AutoSensor from 6 months to 18 months.

P990050/S005

8/6/02

180-Day

WavSTAT™ Optical Biopsy System

SpectraScience, Inc.

Minneapolis, MN

55447

Approval for the WavSTAT™ Optical Biopsy System (OBS) to be extended to include the WavSTAT™ Optical Biopsy System Model III console.

P990074/S012

8/8/02

180-Day

McGhan Saline-Filled Breast Implants

Inamed Corporation

Santa Barbara, CA

93111

Approval for

1. design modifications to the patch configuration,
2. changes to the patch vulcanization process, and
3. changes to the valve vulcanization process.

P990074/S013

8/23/02

180-Day

McGhan Saline-Filled Breast Implants – Styles 68HP and 68LP

Inamed Corporation

Santa Barbara, CA

93111

Approval for the addition of

1. Styles 68HP and 68LP and
2. corresponding package labeling.

P000008/S001

8/26/02

180-Day

BioEnterics LAP-BAND® Adjustable

Gastric Banding System

Inamed Corporation

Santa Barbara, CA

93111

Approval for a manufacturing method change with a corresponding change in material.

P000008/S002

8/1/02

180-Day

Lap-Band® Adjustable Gastric Banding (LAGB®) System

BioEnterics Corporation

Santa Barbara, CA

93111

Approval for the following modifications to the Lap-Band® Adustable Gastric Banding (LAGB®) System:

1. Introduction of a redesigned access port (Access Port II);
2. Replace the calibration tube (Calibration Tube I) currently provided in the LAGB®) System with a redesigned calibration tube (Calibration Tube II); and
3. Introduction of 2" Access Port Needles to be sold as an accessory item. In addition to being sold as components of the LAGB® System, both the Access Port II and the Calibration Tube II will be sold as separate accessories.

P000020/S007

8/19/02

Real-Time

Stinger™,

Stinger™ M, Stinger™ S, and Stinger ™ SM Ablation Catheters with 8F/5mm Distal Electrode

C.R. Bard, Inc.

Lowell, MA

01851

Approval for the line of Stinger catheters configured with an 8F/5mm distal electrode.

P000028/S001

8/13/02

Real-Time

AFFINITY™ Anterior Cervical Cage System

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for the following changes to the device:

1. minor design changes to the cage, mainly consisting of minor changes to the threads;
2. provide the device sterile; and
3. change the device name to the AFFINITY™ Anterior Cervical Cage System. The device, as modified, will be marketed under the trade name AFFINITY™ Anterior Cervical Cage System and is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. AFFINITY™ implants are to be used with autogenous bone graft and implanted via an open anterior approach.

P000043/S004

8/22/02

Real-Time

TMx-2000™ BPH Thermotherapy System

TherMatrx™

Northbrook, IL

60062

Approval to remove the contraindication for patients with prostatic or bladder cancer, and add the precaution stating that the safety and effectiveness of the TherMatrx TMx-2000™ has not been established in patients with clinical or histological evidence of prostate or bladder cancer.

P000046/S002

8/30/02

180-Day

STAARVISC™ II, Shellgel™ and CoEase™ Sodium Hyaluronate Ophthalmic Viscosurgical Devices

Anika Therapeutics, Inc.

Woburn, MA

01801

Approval for an additional cleanroom area.

P000052/S005

8/22/02

180-Day

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for hardware and software changes for the GALILEO™ Source Delivery Unit, i.e., an alternate primary circuit board (AMPRO Board), LCD display and associated software. These changes are applicable to the GALILEO™ Intravascular Radiotherapy System, which consists of the GALILEO™ Source Delivery Unit, the 27 mm 32P source wire and the 27 mm GALILEO™ Centering Catheter.

P000052/S006

8/2/02

180-Day

GALILEO Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for changes to components used in the SDU Head and Cartridge of the GALILEO Intravascular Radiotherapy System. The device modifications include changes to the emergency retract system, the stop collar/wire drives and the cartridge latching mechanism.

P000052/S008

8/9/02

135-Day

GALILEO Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Approval for a manufacturing change, using an automated source wire Quality Control machine as an alternative to manual source wire final testing and inspection.

P950032/S033

8/12/02

Apligraf®

Organogenesis, Inc.

Canton, MA

02021

Elimination of two media feeds of Apligraf during manufacture.

P970008/S022

8/1/02

Urologix Targis™ System

Urologix, Inc.

Minneapolis, MN

55447

Change of supplier for the fiber optic temperature sensor probe component from the Luxtron Corporation in Santa Clara, California to the Urologix facility and a change in the use of an adhesive bonding process to an annealing process on the coolant bag.

P000052/S010

8/2/02

GALILEO™ Intravascular Radiotherapy System

Guidant Corporation

Houston, TX

77054

Amending implementation of manufacturing changes described in P000052/S007, approved April 17, 2002 and adding a verification step to the preventive maintenance checklist for the Galileo Source Delivery Unit.