ATS Open Pivot® Bileaflet Heart Valve

ATS Medical, Inc.

Minneapolis, MN

55447

Approval for the ATS Open Pivot® Bileaflet Heart Valve, Standard Aortic Model 500FA 21, 23, 25, 27, and 29 mm, Standard Mitral Model 500DM 29, 31, and 33 mm, Advanced Performance (AP) Aortic Model 501DA 18, 20, 22, 24, and 26 mm, and AP Mitral Model 501DM 26 and 28 mm. The device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.

HealthTronics OssaTron®

HealthTronics, Inc.

Marietta, GA

30062

Approval for the OssaTron. The device is indicated for use for performing extracorporeal shock wave (ESW) treatment in patients with chronic proximal plantar fasciitis that has failed to respond to conservative treatment. Chronic proximal plantar fasciitis is defined as pain in the area of the insertion of the plantar fascia on the medial calcaneal tuberosity that has persisted for 6 months or more.

Nucleus 24 Auditory Brainstem Implant (ABI) System

Cochlear Corporation

Englewood, CO

80112

Approval for the Nucleus 24 Auditory Brainstem Implant (ABI) System. The device is intended to restore useful hearing via electrical stimulation of the cochlear nucleus. The device is indicated for individuals 12 years of age or older, who have been diagnosed with Neurofibromatosis Type 2 (NF2). Implantation may occur during first or second-side tumor removal, or in patients with previously removed acoustic tumors bilaterally. Because the surgical procedure for tumor excision and electrode placement eliminates residual hearing preoperative audiological criteria are not relevant. Prospective implant recipients and their families should have appropriate expectations, regarding the potential benefits of an auditory brainstem implant and should be highly motivated to participate in the postoperative rehabilitation process.

Medtronic AVE BeStent™ 2 with Discrete Technology™ Over-the-Wire (OTW) & Rapid Exchange (RX) Coronary Stent Delivery Systems

Medtronic AVE Inc.

Santa Rosa, CA

95403

Approval for the Medtronic AVE BeStent™ 2 with Discrete Technology™ Over-the-Wire (OTW) Coronary Stent Delivery System and the Medtronic AVE BeStent™ 2 with Discrete Technology™ Rapid Exchange (RX) Coronary Stent Delivery System. The devices are indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to discrete de novo lesions (length £ 30 mm) in native coronary arteries with reference vessel diameters ranging from 3.0 mm to 4.0 mm.

Gelfoam® Sterile Powder

Pharmacia & Upjohn Company

Kalamazoo, MI

49001

Approval for the addition of bone hemostasis to the indications for use.

SJM® Master Series Hemodynamic Plus (HP) with Flex Cuff™, Model AFHPJ-505

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for a change to the aortic polyester cuff configuration of the SJM® Master Series HP valve. The device, as modified, will be marketed under the trade name SJM® Master Series Hemodynamic Plus (HP) with Flex Cuff™, Model AFHPJ-505, available in aortic sizes 17, 19, 21, 23, 25, and 27 mm.

Integrity AFx DR Model 5342 and SR Model 5142

St. Jude Medical

Sylmar, CA

91342

Approval for modifications to the users manuals for the Integrity AFx DR Model 5342 and SR Model 5142.

Boston Scientific Scimed MAVERICK™ Over-The-Wire (OTW) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter

Boston Scientific Scimed, Inc.

Maple Grove, MN

55311

Approval for the Boston Scientific Scimed MAVERICK™ Over-the-Wire (OTW) Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheter (9, 12, 15, 20, 25 and 30 mm lengths with balloon diameters of 2.0 – 4.0 mm in ¼ mm increments, and 9, 15 and 20 mm lengths with balloon diameters of 1.5 mm). The MAVERICK™ OTW PTCA Catheter is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The MAVERICK™ OTW PTCA Catheter (2.25 – 4.0 mm balloon diameters) is also indicated for the post-delivery expansion of balloon expandable stents.

Integrity AFx DR Model 5342 and SR Model 5142

St. Jude Medical

Sylmar, CA

91342

Approval for modifications to the users manuals for the Integrity AFx DR Model 5342 and SR Model 5142.

Model 9790/9790C Programmer

Medtronic, Inc.

Shoreview, MN

55126

Approval for modification of labeling regarding the VGA video output port on the Model 9790/9790C series programmers, which instructs users to contact Medtronic technical services for guidance in using the port.

Rotablator® Rotational Angioplasty System

Boston Scientific Corporation

Redmond, WA

98052

Approval for a quality control change for receiving inspection to inspect the shuttle spring for sharp edges.

Rotablator® Rotational

Angioplasty System with RotaLink Plus Exchangeable

Boston Scientific Corporation

Redmond, WA

98052

Approval for an additional manufacturing site located at Boston Scientific Cork, Ltd, Cork, Ireland and additional sterilization facility located at Isotron Ireland Ltd., Offaly, Ireland.

Photon™ DR Implantable Cardioverter Defibrillator (ICD) System

St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the Photon™ DR ICD System including the Pulse Generator, (Model V-230HV), Model 3307, V1.3 Programmer Software, Model AC-IP IS-1 Receptable Plug, and Model 442-2 Torque Driver/Torque Wrench. This device is indicated for use in patients with a history of hemodynamically compromising ventricular tachyarrhythmias. These patients may have experienced a cardiac arrest not associated with acute myocardial infarction or have ventricular tachyarrhythmias. In addition, the pulse generator can be used in patients whose primary therapy for hemodynamically significant, sustained ventricular tachycardia is antitachycardia pacing; the defibrillation capabilities of the device provide high-energy therapy in the event that the arrhythmia accelerates. The pulse generator can be implanted in either the pectoral region or the abdominal region, at the physician’s discretion.

ENDOTAK® RELIANCE™ Models 147, 148, 149 and RELIANCE S™ Models 127, 128, 129 Endocardial Defibrillation Leads with Accessory Stylet Models 6771 and 6772

Guidant Corporation

St. Paul, MN

55112

Approval for the ENDOTAK family of defibrillation leads and the accessory stylet kit.

Lead Tunneler Kit Model 6888

Guidant Corporation

St. Paul, MN

55112

Approval for Model 6888 Lead Tunneler Kit after replacing Tunneling Tip Model 6995 with Model 6804 (used with the ENDOTAK RELIANCE / RELIANCE S Leads)

TCI HeartMate® VE LVAS

Thermo Cardiosystems, Inc.

Woburn, MA

01888

Approval to modify the HeartMate VE System Controller (C/N 1215) to accommodate a new four cell Battery Module (Battery Cell), resulting in VE System Controller C/N 1216 and Battery Module C/N 1264.

VISX STAR S2 and S3 Excimer Laser Systems

VISX, Inc.

Santa Clara, CA

95051

Approval for the VISX STAR S2 and S3 Excimer Laser Systems which are indicated for photorefractive keratectomy (PRK) treatments: 1) in patients with documented evidence of a change in manifest refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination; and 2) in patients 21 years of age or older for the reduction or elimination of naturally occurring hyperopia between +0.5 and +5.0 D sphere at the spectacle plane with refractive astigmatism from +0.5 to +4.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D.

Angio-Seal™ EV Vascular Closure Device, 6 and 8 French

St. Jude Medical

Minnetonka, MN

55345

Approval for a device name modification and longer guidewire. The device, as modified, will be marketed under the trade named Angio-Seal™ EV Vascular Closure Device and is indicated for femoral arterial access closure following 8F and 6F diagnostic angiography and interventional (8F only) procedures.

Lead Cap Accessory Kit Model 6623

Guidant Corporation

St. Paul, MN

55112

Approval for the Lead Caps for use with all Guidant compatible leads including the RELIANCE™ and RELIANCE S™ Leads.

Talent and Brio Pacemakers

ELA Medical

Plymouth, MN

55441

Approval to change the header material in the Talent and Brio pacemakers.

Brio Pulse Generators

ELA Medical

Plymouth, MN

55441

Approval for the following modifications to the Brio family of pacemakers: 1) modify the value for the number of cycles the device will allow before a self test is initiated when the sensor "calls for an elevated pacing rate for a duration or frequency that exceeds reasonable physiologic limits" from 30,000 to 100-000 cycles; and 2) changing the minimum sensing threshold during T-wave protection from 2.2 to 2.5mV.

Actros SLR+ Pulse Generators

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for removal of the warning label which recommended programming Dynamic Hysteresis On when the device is programmed to the VDDR mode.

Philos Family of Pulse Generators

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the use of alternative components in the Philos Family of Pulse Generators, specifically: 1) the LITRONIK GmbH & Co Model LiS 3150 Battery; and 2) a Low Temperature Co-fire Ceramic (LTCC) substrate.

The Closer S 6 Fr. Suture Mediated Closure (SMC) System and The Closer 6 Fr. Suture Mediated Closure (SMC) System

Perclose, Inc.

Redwood City, CA

94063

Approval for the Knot Pusher with Trimmer, an accessory to The Closer 6 Fr. SMC System and The closer S 6 Fr. SMC System.

Medtronic® Interstim® System for Urinary Control (Model 3095A lead Extension Kit and Associated Labeling)

Medtronic, Inc.

Minneapolis, MN

55421

Approval for the Model 3095A Lead Extension Kit for use with the MEDTRONIC® Interstim® System for Urinary Control, which is indicated for the treatment of urinary urge incontinence, urinary retention, and significant symptoms of urgency/frequency in patients who have failed or could not tolerate more conservative treatments.

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

Guidant Corporation

Santa Clara, CA

95052

Approval for the ACS Multi-Link RX and OTW Tetra™ Coronary Stent Systems. The devices are indicated for improving coronary lumen 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 a reference vessel diameter of 3.0 mm to 4.0 mm; and 2) treatment of abrupt or threatened abrupt closure in patients with failed interventional therapy in lesions (£ 35 mm in length) with reference diameters in the range of 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 and the 33 mm and 38 mm length stents are solely indicated for use in patients with abrupt or threatened abrupt closure.

Nidek EC-5000 Excimer Laser System

Nidek Technilogies, Inc.

Pasadena, CA

91105

Approval for the incorporation of the nomogram for laser in-situ keratomileusis (LASIK) treatments into the Nidek EC-5000 software, along with the nomogram for PRK for moderate myopia with astigmatism.

LaserScan LSX Excimer Laser

LaserSight Technologies, Inc.

Winter Park, FL

32792

Approval for a manufacturing site located at LaserSight Technologies, Inc. Winter Park, Florida.

Medtronic Sigma Pacing System and Medtronic 350 Series pacing System

Medtronic, Inc.

Minneapolis, MN

55432

Approval for modifications/improvements for the Sigma and 350 Pacing Systems, specifically: 1) Modify the bottom of the connector by adding a 0.020 recess on the underside area between the connector and the can. 2) Add notches to the skirt on the bottom of the connector. 3) Change interconnect ribbon (ICR) material 4) Modify connector ICR area by adding walls between interconnect ribbons. 5) Modify ICR weld configuration. 6) Change material for set screw blocks. 7) Modify 3.2 mm connector bores by modifying the location of the IS-1 lead stop zones. 8) Increase polyurethane thickness on outside of connector in ultrasonic weld zones. 9) Preformed ICRs. 10) Minimum adhesive fill line added around the perimeter of the fill area.

Ancure Endovascular Grafting System

Guidant Cardiac and Vascular Surgery Group

Menlo Park, CA

94025

Approval for enhancements to the manufacturing process for the Ancure System.

AcrySof® Multi-piece Posterior Chamber Intraocular Lens (IOL), Models MA60BM & MA30BA

Alcon Laboratories

Fort Worth, TX

76134

Implementation of an automated final dimensional inspection station.

NIR Premounted Stent Systems

Boston Scientific Scimed, Inc.

Natick, MA

01760

Change to an in-process inspection step to remove the stent imprint as a rejection criterion for the elastomeric retaining sleeve component acceptance.