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PMA Final Decisions Rendered for May 2002

5/22/02

INDERMIL™ Tissue Adhesive

United States Surgical Corporation

Norwalk, CT

06856

Approval for the INDERMIL™ Tissue Adhesive. The device is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly-cleansed, and have easily approximated skin edges. INDERMIL™ may be used in conjunction with, but not in place of, deep dermal stitches.

5/2/02

CONTAK CD CRT-D (Cardiac Resynchronization Therapy Defibrillator) System and EASYTRAK Coronary Venous Steroid-Eluding Single-Electrode Pace/Sense Lead, Models 4510, 4511, 4512 and 4513

Guidant Corporation

St. Paul, MN

55112

Approval for the CONTAK CD CRT-D System and the EASYTRAK Coronary Venous Steroid-Eluding Single-Electrode Pace/Sense Lead, Models 4510, 4511, 4512 and 4513. The CONTAK CD 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. Patient 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 hemodynamically 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. The EASYTRAK Coronary Venous Steroid-Eluding Single-Electrode Pace/Sense Lead, Models 4510, 4511, 4512 and 4513 are transvenous leads intended for chronic left ventricular pacing and sensing via the coronary veins when used in conjunction with a compatible Guidant cardiac resynchronization therapy (CRT) device.

180-Day

PMMA Intraocular Lenses, Models 6190B, 6840B, 6842B, 8590B and MC550

Bausch & Lomb, Inc.

San Dimas, CA

91773

Approval for a new manufacturing facility located at Bausch & Lomb, Inc., Wilmington, Massachusetts. The clear compression molded blank PMMA material will be manufactured at this facility.

180-Day

HighSail™ Coronary Dilatation Catheters

Guidant Corp.

Temecula, CA

92591

Approval to modify the packaging by eliminating the flushing tool and replacing the dispenser tubing coil.

Real-Time

FreshLook® Spherical, Toric and Bifocal (phemfilcon A) Soft (hydrophilic) Contact Lenses for Extended Wear up to 7 days/6 nights (with UV absorber and carbazole violet tint)

CIBA Vision

Duluth, GA

30097

Approval for a change of tint from phthalocyanine green to carbazole violet for FreshLook® Spherical, Toric and Bifocal (phemfilcon A) UV Soft (hydrophilic) Contact Lenses. The device, as modified, will be marketed under the trade name referenced above with the following indication: FreshLook® Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 2.0 diopters that does not interfere with visual acuity. FreshLook® Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to 6.0 diopters. FreshLook® Bifocal (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for the correction of visual acuity and presbyopia in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of up to .75 diopters that does not interfere with visual acuity. The lenses may be prescribed for extended wear in not-aphakic persons from 1-7 days between removal for cleaning and disinfection or disposal, as recommended by the eye care practitioner. The eye care practitioner may prescribe the lens in either a single use disposable program or in a frequent replacement program with cleaning, disinfection, and scheduled replacement. When prescribed in a frequent replacement program, the lens may be disinfected using a chemical (hot heat) disinfection system. FreshLook Lenses with UV absorbing monomer help protect against transmission of harmful UV radiation to the cornea and into the eye.

180-Day

GAMBRO PRISM TPE 2000 Set with Plasmafilter PF2000N

GAMBRO Renal Products

Lakewood, CO

80215

Approval for the permanent bonding of tubing lines onto the Plasmafilter PF2000N. The device, as modified, will be marketed under the trade name PRISM TPE 2000 Set, and is indicated for use in performing therapeutic plasma separation from whole blood in a clinical setting to remove circulating plasma components or protein bound toxins.

180-Day

PMMA Intraocular Lenses, Models 6190B, 6840B, 6842B, 8590B and MC550

Bausch & Lomb, Inc.

San Dimas, CA

91773

Approval for a new manufacturing facility located at Bausch & Lomb, Inc., Wilmington, Massachusetts. The clear compression molded blank PMMA material will be manufactured at this facility.

Real-Time

Medtronic Vascular Catheter

Medtronic Neurological

Minneapolis, MN

55432

Approval for Catheter Model 8708 in which the Straight connector is replaced with Right angle connector, the number of Anchor beads is increased to 12. Also, removal of accessory components specified as Guide wire, Tunneling accessories and two Pre-attached Anchors from Model 8700A, 8700V and 8702 Package. The device, as modified, will be marked under the trade name Medtronic Vascular Catheter Model 8708 and is indicated for use with the Medtronic® Implantable infusion pumps to provide fluid pathway.

Real-Time

SynchroMed Infusion Pump System

Medtronic, Inc.

Minneapolis, MN 55432

Approval for the following changes to intrathecal Catheter Model 8711: 1) addition of numerical markings (in cm) on the catheter tubing,

2) change in V-wing anchor material for improved visibility, 3) removal of proximal anchor; tunneling rod tips and wrench from the catheter kit, and

4) update Model 8711 technical manual to provide detailed instructions and cautions.

180-Day

Pro Osteon 500 Bone Graft Substitute

Interpore Cross International

Irvine, CA

92618

Approval to replace static compression testing with ultimate compression testing during the manufacturing process following depyrogenation.

180-Day

BOSTON® EQUALENS® (itafluorofocon A) Rigid Gas Permeable Contact lens

Bausch & Lomb, Vision Care

Rochester, NY

14603

Approval for an aspheric design for extended wear and labeling changes for the device. Requested labeling changes include: 1) Change from the title "Patient Instructions" to "Patient Care Guide". 2) Update the prescription caution statement. 3) Modify the Product Description Section of the Package Insert and Professional Fitting and Information Guide as follows:

a) add the descriptions for both the aspheric design (extended and daily wear) and the previously approved bifocal lens (daily wear only) and specify daily wear for the toric and bifocal designs;

b) remove from these Product Description Sections the phrase "without UV" because this option is no longer available; and

c) change the color name of the blue lens material from "Dark Blue" to "Electric Blue".

4) Correct the manufacturer’s address. 5) Update the wording of the UV Warning and clarify the extended wear indication as in the indication stated below.

"The Boston Equalens (itafluorofocon A) RGP contact lens is indicated for daily or extended wear from 1 to 7 days between removals for cleaning and disinfection as recommended by the eye care practitioner. The lens is indicated for extended wear for the correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes in powers from -20.00D to +12.00D. The lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be disinfected using a chemical disinfection system only."

180-Day

Various Posterior Chamber Intraocular Lenses

Allergan, Inc.

Irvine, CA

92623

Approval for the alternate sterilization facility located at Edwards Lifesciences LLC, Anasco, Puerto Rico.

180-Day

Hepacoat on Bx Sonic Balloon-Expandable tent OTW Delivery System

Cordis Corporation

Miami, FL

33102

Approval 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; 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 4.00 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.

Special

BX VELOCITY™ Stent on RAPTORRAIL™ Stent Delivery System (RX) and BX Velocity™ Stent with HEPACOAT on RAPTORRAIL™ Stent Delivery System (RX)

Cordis Corporation

Warren, NJ

07059

Approval for four changes to the quality plan for the device.

Real-Time

RF Enhancer™ 7French, 5 mm Ablation Catheter, Model Numbers 11744523, 11745523, 11745533, 19745533, 19746534, 21744523, 21745523, 29745533, and 29746534

Medtronic, Inc.

Minneapolis, MN

55432

Approval for ablation catheters which feature design changes to the Performer catheter. The device, as modified, will be marked under the trade name RF Enhancer 7French, 5 mm Ablation Catheter and is indicated for use with the Medtronic RF power generator to deliver RF energy for intracardiac ablation of accessory atrioventricular (AV) conduction pathways associated with tachycardia for the treatment of AV nodal re-entrant tachycardia and for creation of complete AV block in patients with a difficult to control ventricular response to an atrial arrhythmia.

180-Day

WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems

Boston Scientific Scimed

Maple Grove, MN

55311

Approval for an alternate manufacturing facility for the stent component of the Wallstent® Products located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland.

180-Day

WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems

Boston Scientific Scimed

Maple Grove, MN

55311

Approval for an alternate manufacturing facility for the stent component of the Wallstent® Products located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland.

180-Day

BAK Interbody Fusion System, BP/Lordotic Device

Sulzer Spine-Tech, Inc.

Minneapolis, MN

55439

Approval to add the BP/Lordotic to the approved product line for the BAK Interbody Fusion System. The device, as modified, will be marketed under the trade name BP/Lordotic and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at the L4-L5 and/or L5-S1 levels. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). BP/Lordotic devices are to be implanted via an open anterior or laparoscopic approach. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

180-Day

Various Posterior Chamber Intraocular Lenses

Allergan, Inc.

Irvine, CA

92623

Approval for the alternate sterilization facility located at Edwards Lifesciences LLC, Anasco, Puerto Rico.

180-Day

MemoryLens® Model U940A UV-Absorbing Hydrophilic Posterior Chamber IOL

CIBA Vision Corporation

Duluth, GA

30097

Approval for changes in the manufacturing processes for the MemoryLens® IOL.

180-Day

12F and 14F Laser Sheath Kits (Models 500-001 and 500-012)

Spectranetics Corporation

Colorado Springs, CO

80907

Approval for a modification to the 12F and 14F Laser Sheath Kits (Models 500-001 and 500-012).

Real-Time

Closer™ AK 6Fr. Suture-Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for manufacturing and material design changes, i.e., changing to a press-fit handle, to a green and white suture, to an internal suture storage, changing the thumb cap/plunger attachment back to what was previously approved in P960043/S036, and a change in the O-ring material. In addition, the labeling is being modified to include other healthcare professionals in the precaution on the limitation of use to physicians who have been trained in the use of this device. The device, as modified, will be marketed under the trade name Closer™ AK 6Fr. Suture-Mediated Closure (SMC) System 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 Closer™ 6 Fr. SMC Systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions (refer to Precautions, Special Patient Populations).

180-Day

ACS Multi-Link® Coronary Stent System – Post-approval Study

Guidant Corporation

Santa Clara, CA

95054

Approval of the post-approval study for the device.

180-Day

Multi-Link RX and OTW Penta™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95054

Approval for inclusion of six-month trial data in the Instructions for Use booklet for the Multi-link RX and OTW Penta™ Coronary Stent Systems. The Multi-Link RX and OTW Penta™ Coronary Stent Systems are indicated for improving coronary luminal diameter in the following: 1) Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with reference vessel diameters of 3.0 mm to 4.0 mm; 2) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with reference vessel diameters ranging from 3.0 to 4.0 mm; and 3) Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference vessel diameters ranging from 2.5 mm to 4.0 mm. Long term outcome for this permanent implant is unknown at present. Note: The 2.5 mm and 2.75 mm diameter stents are solely indicated for use in patients with abrupt or threatened abrupt closure. The 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure and patients with lesions in saphenous vein bypass grafts.

180-Day

Multi-Link RX and OTW Tetra™ Coronary Stent Systems

Guidant Corporation

Santa Clara, CA

95054

Approval for inclusion of six-month trial data in the Instructions for Use booklet for the Multi-Link RX and OTW Tetra™ Coronary Stent Systems. The Multi-Link RX and OTW Tetra™ Coronary Stent Systems are indicated for improving coronary luminal diameter in the following:

1) Patients with symptomatic ischemic disease due to discrete de novo or restenotic native coronary artery lesions (length <= 25 mm) with reference vessel diameters of 3.0 mm to 4.0 mm; 2) Patients with symptomatic ischemic heart disease due to lesions in saphenous vein bypass grafts (length <= 35 mm) with reference vessel diameters ranging from 3.0 to 4.0 mm; and

3) Treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (<= 35 mm in length) with reference vessel diameters ranging from 2.5 mm to 4.0 mm. Long term outcome for this permanent implant is unknown at present. Note: The 2.5 mm and 2.75 mm diameter stents are solely indicated for use in patients with abrupt or threatened abrupt closure. The 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure and patients with lesions in saphenous vein bypass grafts.

180-Day

WALLSTENT® (TIPS, Iliac, Venous) Endoprosthesis with Unistep Plus Delivery Systems

Boston Scientific Scimed

Maple Grove, MN

55311

Approval for an alternate manufacturing facility for the stent component of the Wallstent® Products located at Boston Scientific Ireland Ltd. (BSIL), Galway, Ireland.

180-day

Various Posterior Chamber Intraocular Lenses

Allergan, Inc.

Irvine, CA

92623

Approval for the alternate sterilization facility located at Edwards Lifesciences LLC, Anasco, Puerto Rico.

Panel

TECHNOLAS® 217A Excimer Laser System

Bausch & Lomb Surgical

San Dimas, CA

91773

Approval the TECHNOLAS 217A Excimer Laser System. This device is indicated for laser in-situ keratomileusis (LASIK) treatments: 1) for the reduction or elimination of myopic astigmatism up to -12.00 D MRSE, with sphere between >-7.00 D to -10.99 D and cylinder between 0.00 and <-3.00 D; 2) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination; and, 3) in patients who are 21 years of age or older.

180-Day

Sunlight Omnisense™ 7000S Ultrasound Bone Sonometer

Sunlight Medical Ltd.

Rehovot, Isreal

76100

Approval for changing the manufacturing calibration software by adding a new specification and test methods that limits the amplitudes of the three different probes which are used for the approved multiple skeletal sites to less than 520mV and normalizes the probes to predefined values of approximately 400mV.

180-Day

Vascular Solutions Duett™ Sealing Device

Vascular Solutions, Inc.

Minneapolis, MN

55441

Approval for modifications to the delivery cannulae and the procoagulant and changing the buffering agent in the dilutent to Tromethamine USP (TRIS). The device, as modified, will be marketed under the trade name Duett Flowable Hemostat Device and is indicated for use as adjunct treatment in obtaining hemostasis in sealing residual oozing of tissue tracts of femoral access sites that have been previously closed by suture mediated/collagen-based hemostatic devices.

180-Day

ATS Open Pivot Bileaflet Heart Valve

ATS Medical, Inc.

Minneapolis, MN

55447

Approval to transfer the manufacturing of the pyrolytic carbon coated heart valve components from Sulzer Carbomedics, Inc., to ATS Medical Inc., Minneapolis, Minnesota.

180-Day

Hyperion LTK System

Sunrise Technologies

Fremont, CA

94538

Approval for a manufacturing site located at A-Plus/C-MAC, Fremont, California.

180-Day

Lap-Band Adjustable Gastric Banding System

BioEnterics Corporation

Santa Barbara, CA

93111

Approval for a manufacturing site located at McGhan Medico, Barreal de Heredia, Costa Rica.

180-Day

Novoste™ β-Cath™ XL Delivery Catheter

Novoste Corporation

Norcross, GA

30093

Approval for the Novoste™ β –Cath™ XL Delivery Catheter (total length 267 cm.) to be used with the 30 and 40 mm Novoste™ Beta-Cath™ Systems.

Special

AMPLATZER® Septal Occluder (ASO) Device

AGA Medical Corporation

Golden Valley, MN

55427

Approval for the addition of a caution label.

180-Day

TMx-2000 BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval for a new manufacturing site located at Manufacturing and Research, Inc., Tucson, Arizona. The RX-200 applicator will be manufactured at this facility.

Real-Time

CoEase™ Sodium Hyaluronate

Anika Therapeutics, Inc.

Woburn, MA

01801

Approval for a private distributor agreement with Advanced Medical Optics. The device will be marketed under the trade name CoEase Sodium Hyaluronate and will be distributed in volumes of 0.5 ml and 0.8 ml.

180-Day

Contak CD and EasyTrak Lead System

Guidant Corporation

St. Paul, MN

55112

Approval of the post-approval study for the device.

180-Day

NovaSure™ Impedance Controlled Endometrial Ablation System

Novacept, Inc.

Palo Alto, CA

94303

Approval for a revised patient brochure.

180-Day

Attain™ OTW 4193 Left Ventricular Pacing Lead

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Attain OTW 4193 Left Ventricular Pacing Lead. The Model 4193 is indicated for use as part of a Medtronic biventricular pacing system.

180-Day

Medtronic® InSync® Biventricular Pacing System including the Model 8040 InSync® Pulse Generator, the Model 9980 Programmer Software, and the Attain™ LV Model 2187 and Attain™ CS Model 2188 Leads

Medtronic, Inc.

Minneapolis, MN

55432

Approval of the post-approval study for the device. The post-approval study has been submitted to comply with the conditions of approval outlined in the August 28, 2001 approval order for P010015.

180-Day

Second Look® 4.0 System

Parexel International

Waltham, MA 02451

Approval for an overall upgrade to the hardware and software in the device. These changes improved the sensitivity, decreased the marks per case and made an improvement in false negatives. In addition, soft-copy, increased storage, and DICOM interfacing were added along with sundry other operating improvements.

5/15/02

PROSORBA Column

Fresenius HemoCare, Inc.

Redmond, WA

98052

Reduction in the time of the reaction step in the manufacturing process and a decrease in the amount of carbodiimide used in the process.

5/31/02

BX VELOCITY™ Balloon Expandable Stent with RAPTOR™ OTW Delivery System and BX VELOCITY™ Stent with HEPACOAT™ on RAPTOR™ OTW Delivery System

Cordis, Inc.

Warren, NJ

07059

Modification in the stent crimping process.

5/2/02

Rotablator Rotational Angioplasty System

Boston Scientific Scimed, Inc.

Maple Grove, MN 55311

Change to the manufacturing process for the Rotablator Rotational Angioplasty System. The change involves a reduction in the number of audit samples taken for destructive pull testing from the laser subassembly line.

5/1/02

NIR® Stent Delivery Systems

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Manufacturing process change to remove the stent securement audit.

5/7/02

Kappa 700 Series of Implantable Pulse Generators

Medtronic, Inc.

Minneapolis, MN

55432

Change in the controlled environmental area from Class 10,000 to a minimum of Class 100,000.