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PMA Final Decisions Rendered for March 2004

P010058

3/15/04

OSTEOSPACE

MEDILINK

Carnon, France

F34280

Approval for the OSTEOSPACE.  The OSTEOSPACE is a quantitative ultrasound bone sonometer device (QUS) to be used for the measurement of broadband ultrasound attenuation (BUA) of the calcaneus, as an aid, together with other clinical risk factors, to diagnose osteoporosis and other medical conditions leading to reduced bone strength and to estimate the risk of subsequent atraumatic fracture.  The output is expressed in terms of BUA, T-score, and Z-score.

P030024

3/4/04

Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator

Ortho-Clinical Diagnostics, Inc.
Rochester, NY
14626

Approval for the Vitros Immunodiagnostic Products Anti-HBc Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc Calibrator. These devices are indicated for: 1) Vitros Immunodiagnostic Products Anti-HBc Reagent Pack is indicated for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human adult and pediatric serum and plasma (EDTA and citrate) and neonate serum using the Vitros ECi Immunodiagnostic System. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B, or recovery from hepatitis B infection. The presence of anti-HBc may be used as an aid in the determination of exposure to HBV infection for individuals prior to HBV vaccination. 2) Vitros Immunodiagnostic Products Anti-HBc Calibrator is indicated for use in the calibration of the Vitros ECi Immunodiagnostic System when used for the in vitro qualitative detection of total antibody (IgG and IgM) to hepatitis B core antigen (total anti-HBc) in human adult and pediatric serum and plasma (EDTA and citrate) and neonate serum using Vitros Anti-HBc Reagent Packs..

P030025

3/4/04

TAXUS™ Express²™ Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire)

Boston Scientific Corporation

Natick, MA

01760

Approval for the TAXUS Express² Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire).  The device is indicated for improving luminal diameter for the treatment of de novo lesions <28 mm in length in native coronary arteries ≥ 2.5 to ≤ 3.75 mm in diameter.

P030026

3/4/04

Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator

Ortho-Clinical Diagnositc, Inc.

Rochester, NY

14626

Approval for the Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator. These devices are indicated for: 1) Vitros Immunodiagnostic Products Anti-HBc IgM Reagent Pack is indicated for the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (heparin, EDTA and citrate) and neonate serum using the Vitros ECi Immunodiagnostic System. Assay results, in conjunction with other serological and clinical information, may be used for the laboratory diagnosis of individuals with acute or chronic hepatitis B. 2) Vitros Immunodiagnostic Products Anti-HBc IgM Calibrator is indicated for the use in the calibration of the Vitros Immunodiagnostic System for the in vitro qualitative detection of IgM antibody to hepatitis B core antigen (anti-HBc IgM) in human adult and pediatric serum and plasma (EDTA, heparin or citrate) and neonate serum using Vitro Anti-HBc IgM Reagent Packs.

P810046/S214

3/12/04

180-Day

VOYAGER™ OTW Coronary Dilatation Catheter

Guidant Corporation

Temecula, CA

92591

Approval for a new coronary dilatation catheter.  The device, as modified, will be marketed under the trade name VOYAGER™ OTW Coronary Dilatation Catheter and is indicated for  1) balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion, 2) balloon dilatation of a coronary artery occlusion for the purpose of restoring coronary flow in patients with ST-segment elevation myocardial infarction, 3) balloon dilatation of a stent after implantation. 

P840064/S025

3/5/04

Real-Time

DUOVISC® Viscoelastic System

Alcon Laboratories

Fort Worth, TX

76134

Approval to modify the pH release and stability specification ranges for PROVISC® Ophthalmic Viscosurgical Device contained within the DUOVISC® Viscoelastic System from pH 7.0-7.3 to pH 7.0-7.4 for release and pH 7.0-7.5 to pH 6.8-7.5 for stability.

P860004/S059

3/17/04

Real-Time

SynchroMed and SynchroMed II Implantable Infusion Pumps

Medtronic Neurological

Minneapolis, MN

55432

Approval for: the addition of time labels and a daily dose filed to the programming screens; the addition of recently approved catheter models, Model 8731 and Model 8749, to the drop-down list; changes to the screen used to enter the DEMO mode, and the resulting updates to the programming guides.

P860004/S060

3/29/04

Real-Time

SynchroMed® II Programmable Drug Infusion System

Medtronic, Neurological

Minneapolis, MN

55432

Approval for the following changes involving the motor coil for the SynchroMed® II Implantable Infusion Pump:  1) change from a crimped to a heat-welded motor coil connector pin; and 2) change to a silicon varnish surface coating of the motor coil, the same coating as applied to the motor coil of the SynchroMed® El Implantable Infusion Pump.

P880070/S010

3/17/04

Real-Time

Model HSM65 UV Absorbing PMMA Anterior Chamber Lens

Pharmacia & Upjohn Company

Pickerington, OH

43147

Approval to change the material and the manufacturing process, to add a heparin surface modification, and to change the lens model designation form UV65B to HSM65.

P890003/S074

3/8/04

Real-Time

Medtronic Model 2490D CareLink Monitors and Model 2491 DDMA Software for EnPulse Models E2DR01, E1DR03, E1DR06, E1DR21, E2VDD01, E2SR01, E2SR03, E2SR06, E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33 and Kappa Models 600/700/800/900 devices

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D CareLink Monitor and Model 2491 DDMA Software to allow their use with EnPulse and Kappa 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.

P890047/S016

3/5/04

Real-Time

PROVISC® Ophthalmic Viscosurgical Device

Alcon Laboratories

Fort Worth, TX

76134

Approval to modify the pH release and stability specification ranges for PROVISC Ophthalmic Viscosurgical Device contained within the DUOVISC Viscoelastic System from pH 7.0-7.3 to pH 7.0-7.4 for release and pH 7.0-7.5 to pH 6.8-7.5 for stability.

P890055/S018

3/25/04

Real-Time

Codman Series 3000 Implantable Infusion Pumps

Codman & Shurtleff, Inc.

Raynham, MA

02767

Approval for the following:  minor design and material modifications to the connector; addition of a silicone strain relief sleeve; and minor design and material modifications to the anchors.

P900009/S018

3/12/04

Real-Time

Exogen 2000+ and Exogen 3000

Smith & Nephew, Inc.

Memphis, TN

38116

Approval for two design and component changes: 1) Changes to Exogen 2000+ printed circuit board to implement corrective action for field failure and returns.  This corrective action involves two design changes: i) Replace 2 diodes on te printed circuit board with light emitting diodes. ii) Add a 1000 pF capacitor to reduce electrical noise.  2) Replace both Exogen 2000+ and Exogen 3000 transducer cables with a more cost effective model.

P900043/S042

3/4/04

180-Day

Bx VELOCITY™ Stent with Raptor™ Over-the-Wire (OTW) or RAPTORRAIL™ (RX) Stent Delivery Systems (SDS) – Saphenous Vein Graft (SVG) Indication

Cordis Corp.

Miami Lakes, FL

33014

Approval for a new Saphenous Vein Graft (SVG) Indication for the Bx VELOCITY™ Stent with Raptor™ Over-the-Wire (OTW) or RAPTORRAIL™ (RX) Stent Delivery Systems (SDS).  The device is indicated for the 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; 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; and, Patients with de novo or restenotic saphenous vein graft lesions (< 30 mm in length) with reference diameters ranging from 3.0 mm to 5.0 mm

P910007/S006

3/3/04

180-Day

Abbott AxSYM® Total PSA

Abbott Laboratories

Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Health Products, Inc., Barceloneta, Puerto Rico.

P910073/S043

3/2/04

Real-Time

ENDOTAK® RELIANCE ® G/SG Lead Models 0180-0187

Guidant Corporation

St. Paul, MN

55112

Approval for addition of an ePTFE coating to the shock coils.  The device, as modified, will be marketed under the trade name ENDOTAK® RELIANCE® G/SG Lead Models and is indicated for providing pacing and rate-sensing and to deliver cardioversion and defibrillation shocks for ICD automatic implantable cardioverter defibrillator systems. 

P930038/S037

3/24/04

180-Day

Trac-Sure™ Tissue Tract Accessory

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval for the Trac-Sure™ Tissue Tract Accessory device.  The Trac-Sure Tissue Tract Accessory is indicated for use in conjunction with the Angio-Seal STS and Angio-Seal STS Plus  Vascular Closure Devices in instances where puncture site tissue tract bleeding is noted after hemostasis is achieved with either of these two Angio-Seal devices.  This accessory is an aid in managing puncture site tissue tract non-pulsatile bleeding which occurs after hemostasis is achieved with the Angio-Seal STS or STS Plus Vascular Closure Devices.

P950019/S014

3/25/04

180-Day

Ray TFC and Ray TFC Unite

Stryker Howmedical Osteonics

Allendale, NJ

07401

Approval for a manufacturing site located at Stryker Spine, Cestas, France.

P950037/S032

3/31/04

180-Day

Protos DR/CLS, Protos VR/CLS, Axios DR, Axios D, Axios S, Axios SR, and Axios SLR Pulse Generators with Programmer Software Version SWM 1000 B-K00.PU and Data Transfer Utility v1.0

BIOTRONIK, Inc.

Lake Oswego, OR

97035

 Approval for adding AxVx adaptive rate pacing capability to the Protos family of pulse generators, the addition of the Data Transfer Utility software, and modifications to the Axios family of pulse generators.

P950037/S034

3/8/04

180-Day

Selox SR Steroid-Eluting Active Fixation Endocardial Pacing Lead Models SR45, SR53, SR60

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for addition of a drug collar to the pacing lead.  The device, as modified, will be marketed under the trade name Selox SR and is indicated as following:  Botronik’s SELOX SR transvenous, steroid-eluting, active fixation endocardial leads are indicated for permanent pacing and sensing.  Active fixation pacing leads with a bipolar (BP) IS-1 connector configuration are designed for use in conjunction with implantable pulse generators with IS-1 headers.  The leads may be used with single or dual chamber pacing systems.  The SELOX SR lead models are intended for placement in either the right atrium or right ventricle.

P950037/S036

3/31/04

180-Day

Philos II DR, Philos II D, Philos II DR-T, Philos II SLR, Philos II SR, Philos II S, and programmer software version A-K00.2.U

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for additional features added to the Philos family of pacemakers. The device, as modified, will be marketed under the trade name Philos II and is indicated as follows: Rate-adaptive pacing with the Philos II pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity. Generally accepted indications for long-term cardiac pacing include, but are not limited to: sick sinus syndrome (i.e. bradycardia-tachycardia syndrome, sinus arrest, sinus bradycardia), sino-atrial (SA) block, second- and third- degree AV block, and carotid sinus syndrome. Patients who demonstrate hemodynamic benefit through maintenance of AV synchrony should be considered for one of the dual chamber or atrial pacing modes.  Dual chamber modes are specifically indicated for treatment of conduction disorders that require both restoration of rate and AV synchrony such as AV nodal disease, diminished cardiac output or congestive heart failure associated with conduction disturbances, and tachyarrhythmias that are suppressed by chronic pacing.

Philos II SLR pulse generators are primarily intended to provide VDD or VDDR pacing for patients with a healthy sinus node and AV conduction abnormalities.  These modes are indicated for patients who need ventricular pacing when adequate atrial rates and adequate intracavitary atrial complexes are present.  This includes the presence of complete AV block when: 1) Atrial contribution is needed for hemodynamic benefit and 2) Pacemaker syndrome had existed or is anticipated. Additional indications include normal sinus rhythm and normal AV conduction in patients who intermittently need ventricular pacing support.

P950037/S037

3/31/04

Real-Time

Philos DR-T Pulse Generator and A-K00.1.U/5 Programmer Software

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for the addition of two Cardio Report triggers for the Philos DR-T pulse generator and for revisions to the A-K00.1.U/5 Programmer Software which are necessary in order to utilize the modified Philos DR-T.

P960025/S010

3/17/04

180-Day

Lumbar I/F Cage System

DePuy AcroMed

Raynham, MA

20767

Approval for a manufacturing site located at DePuy AcroMed Sarl, LeLocle, Switzerland.

P960025/S011

3/5/04

180-Day

Saber Lumbar I/F Cage, Jaguar Lumbar I/F Cage

DePuy Acromed, Inc.

Raynham, MA

02767

Approval for the Saber Lumber I/F Cage.  In addition, this supplement requested the approval of two new sizes, which will now be marketed as the Jaguar Lumbar I/F Cage.  These devices are indicated for an open posterior approach using autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1 whose condition requires the use of interbody fusion combined with posterolateral fusion (360 degrees fusion) and posterior pedicle screw fixation .  These patients may have had previous non-fusion spinal surgery at the involved spinal levels(s).  DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies.

P960040/S039

3/8/04

Real-Time

Vitality 2 AICD System (Models T165, T167, T175, T177), Model 2857 Application Software (Version 2.2) and Quick Profiles Disk (Model 2828 Version 1.0)

Guidant Corporation

St. Paul, MN

55112

P960040/S041

3/9/04

Real-Time

VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856), VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858), VENTAK PRIZM® 2 AICD system (Models 1860, 1861), VITALITY® DS/EL AICD system (Models T125, T127, T135), application Software Model 2844 Version 3.7

Guidant Corporation

St. Paul, MN

55112

Approval for the firmware modifications of the following AICD systems:  VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856) firmware version 1.2 Patch H, VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858) firmware version 1.2 Patch H, VENTAK PRIZM® 2 AICD system (Models 1860, 1861) firmware version 1.4 Patch C,  VITALITY® DS/EL AICD system (Models T125, T127, T135) firmware version  1.0 Patch B, CONTAK CD® 2 (Models H115, H119) firmware version 1.2 Patch H, and the Application Software Model 2844 Version 3.7. 

P960040/S042

3/19/04

Real-Time

VENTAK VITALITY® AVT AICD System (Model A135)

Guidant Corporation

St. Paul, MN

55112

Approval for the System Guide labeling reinsert (Change Tachy Mode with Magnet feature).

P960043/S052

3/18/04

Real-Time

Perclose® ProGlide™ 6 French Suture Mediated Closer (SMC) System

Abbott Vascular Devices

Perclose, Inc.

Redwood City, CA

94063

Approval for changing to a new suture vendor (Surgipro II Monofilament Polypropylene Suture.)

P970020/S045

3/22/04

180-Day

Multi-Link Coronary Stent System

Guidant Corporation Temecula, CA

92591

Approval for a sterilization site located at Guidant Corporation, Guidant Ireland, Clonmel, Ireland.

P980016/S040

3/8/04

Real-Time

Medtronic Onyx System, Device Model 7290Cx and Software Model 9999

Medtronic, Inc.

Minneapolis, MN

55432

Approval for device modifications to the GEM II/II I VR Systems.  The device, as modified, will be marketed under the trade name Medtronic Onyx System, Device Model 7290Cx and Software Model 9999 and is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.

P980023/S016

3/12/04

Real-Time

Kentrox SL ICD Leads Model 65/16, 65/18, 75/16, 75/18, 100/16, 100/18

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for changes in component dimensions.  The device, as modified, will be marketed under the trade name Kentrox SL and is indicated for use in conjunction with a BIOTRONIK ICD.  Currently, data is not available regarding the use of this lead system with ICDs of other manufacturers.  Use of other ICDs may adversely affect sensing and/or therapy delivery. 

P980035/S035

3/8/04

Real-Time

Medtronic Model 2490D CareLink Monitors and Model 2491 DDMA Software for EnPulse Models E2DR01, E1DR03, E1DR06, E1DR21, E2VDD01, E2SR01, E2SR03, E2SR06, E2DR01, E2DR03, E2DR06, E2DR21, E2DR31, E2DR33 and Kappa Models 600/700/800/900 devices

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Model 2490D CareLink Monitor and Model 2491 DDMA Software to allow their use with EnPulse and Kappa 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.

P980035/S036

3/31/04

Real-Time

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of the Atrial Capture Management (ACM) and Post Mode Switch Overdrive Pacing (PMOP) features to EnPulse™ Implantable Pulse Generator Models E1DR01, E1DR03, E1DR06, and E1DR21.  In addition, you requested approval for minor updates to the associated programmer software. The device, as modified, will be marketed under the trade name EnPulse™ Implantable Pulse Generator Models E1DR01, E1DR03, E1DR06, E1DR21 and Model 9991 v 2.0 Application Software. 

P980049/S012

3/15/04

Special

ELA Medical, Inc.

Plymouth, MN

55441

Approval for changes to the labeling to include a more accurate battery longevity data.

P980049/S013

3/16/04

Real-Time

ELA Medical, Inc.

Plymouth, MN

55441

Approval for Elaview 1.22 UG1 application software for the Orchestra programmer, RAM Patch P2 for Alto 2 ICD system, RAM Patch TI V5 for Symphony and ELA Rhapsody pacemakers, and HSO 2.68 software and V10+ hardware for the CPR3 Programming Head.

P990033/S005

3/15/04

180-Day

Dentsply CeraMed Dental

Lakewood, CO

80228

Approval for: 1) The addition of a paste form of PepGen P-15,  2) Modification of the device labeling for all PepGen P-15 devices, and  3) Changing of the contract manufacturer for the device carrier to Hyaluron, Inc., Woburn, Massachusetts.

P990080/S004

3/1/04

180-Day

Pharmacia and Upjohn Company

Kalamazoo, MI

49001

Approval to revise the package insert with claims regarding reduction in postoperative spherical aberrations compared to lenses with spherical optics and improved night driving simulator performance.  The device, as modified, will be marketed under the trade name Tecnis™ and is indicated for primary implantation for the visual correction of aphakia in adults in whom a cataractous lens has been removed by phacoemulsifi-cation.  The lenses are intended to be placed in the capsular bag.

P000009/S008

3/19/04

180-Day

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for the Belos A+ and Belos A+/T ICD and Kainox A+ ICD Lead (single-lead system).  It is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

P000032/S004

3/31/04

180-Day

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a manufacturing facility located at American Medical Systems, Inc., Minnetonka, Minnesota.

P000052/S021

3/4/04

135-Day

Guidant Corporation

Houston, TX

77054

Approval for a change to the P-32 Source Wire Manufacturing Process to incorporate an automated Source Wire Assembly Station (SWAS) as an alternate process for final assembly of P-32 Source Wires.

P000052/S023

3/16/04

Real-Time

Guidant Corporation

Houston, TX

77054

Approval to implement a new software revision, Version 63-033/N.  The software was revised to increase the Distal Stop Force of the Active Source Wire.

P000053/S002

3/16/04

Real-Time

American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for revision of the labeling to describe an alternate surgical approach (i.e., transverse scrotal implantation).

P000058/S007

3/30/04

Special

Medtronic Sofamor Danek

Memphis, TN

38132

Approval for a modification to the package insert.  Specifically, adding the following additional events to the “Possible Adverse Events” section of the insert: “Edema (swelling), inflammation, erythematous, allergic reaction, dysphasia, itching, anaphylactic reaction, elevated erythrocyte sedimentation rate, pain, hematoma.”

P010012/S023

3/9/04

Real-Time

Guidant Corporation

St. Paul, MN

55112

Approval for the firmware modifications of the following AICD systems:  VENTAK PRIZM® AICD system (Models 1850, 1851, 1855, 1856) firmware version 1.2 Patch H, VENTAK PRIZM® HE AICD system (Models 1852, 1853, 1857, 1858) firmware version 1.2 Patch H, VENTAK PRIZM® 2 AICD system (Models 1860, 1861) firmware version 1.4 Patch C,  VITALITY® DS/EL AICD system (Models T125, T127, T135) firmware version  1.0 Patch B, CONTAK CD® 2 (Models H115, H119) firmware version 1.2 Patch H, and the Application Software Model 2844 Version 3.7. 

P010018/S005

3/16/04

180-Day

ViewPoint™ CK® System

Refractec, Inc.

Irvine, CA

92618

Approval for the ViewPoint™ CK® System.  The device is indicated for the temporary induction of myopia (-1.00 D to -2.00 D) to improve near vision in the non-dominant eye of presbyopic hyperopes or presbyopic emmetropes, via spherical hyperopic treatment of 1.00 to 2.25 D, in patients:  1) 40 years of age of greater; 2) with a documented stability of refraction for the prior 12 months, as demonstrated by a change of <0.50 D in spherical and cylindrical components of the manifest refraction; 3) with <=0.75 D of cycloplegic refractive cylinder; and 4) with a successful preoperative trial of monovision or history of monovision wear (i.e., dominant eye corrected for distance vision and non-dominant eye corrected for near vision).

P010025/S004

3/2/04

Real-Time

Selenia Full Field Digital Mammography System

Lorad, A Hologic Co.

Danbury, CT

06810

Approval for Selenia FFDM system for use in a mobile environment and QC Manual changes.

P010059/S001

3/15/04

180-Day

Alcon® ReFORM® Capsular Tension Rings

Morcher GmbH

Stuttgart, Germany

D-70374

Approval for a private label distributor agreement with Alcon Laboratories, Inc., Fort Worth, Texas.  The device will be marketed under the trade name Alcon ReFORM Capsular Tension Rings (Models ACTR10, ACTR11, and ACTR12).

P020036/S002

3/19/04

Real-Time

S.M.A.R.T.™ Control™ Nitinol Stent System

Cordis Corporation Miami Lakes, FL

33014

Approval for the following change to the deliver system of the S.M.A.R.T.™ Control™ Nitinol Stent System:

1) The wire lumen of the delivery system  will be fabricated from different materials. 2) The new wire lumen inner diameter specification has been increased. 3) The proximal land section of the distal tip has been increased. 4) The inner diameter specification of the distal tip has been increase.

P020047/S002

3/22/04

180-Day

Multi-Link Vision Coronary Stent System

Guidant Corporation

Temecula, CA

92591

Approval for a sterilization site located at Guidant Corporation, Guidant Ireland, Clonmel, Ireland.

P930039/S018

3/10/04

Medtronic Model 5076 Lead

Medtronic, Inc.

Minneapolis, MN

55432

Use of Med-2000 silicone adhesive as an alternative for Med-1137 silicone adhesive.

P960022/S004

3/4/04

Softlens66® Toric (alphafilcon A) Visibility tinted Contact Lens

Bausch and Lomb

Rochester, NY

14609

Addition of an automated inspection process for the Softlens66®.

P970003/S053

3/3/04

VNS Therapy™ System

Cyberonics, Inc.

Houston, TX

77058

Changes in the manufacturing process to propose using Cyberonics, Inc. as an additional in-house facility for bioburden testing on products and reducing the frequency of sampling of tunneling tools and accessory packs.

P970003/S054

3/3/04

VNS Therapy™ System

Cyberonics, Inc.

Houston, TX

77058

Manufacturing process change to reduce the minimum vacuum bake process time for the Cyberonics Models 102/102R pulse generators.

D970012/S020

3/24/04

AMS 700 Series Product Line Inflatable Penile Prosthesis

American Medical Ssytems

Minnetonka, MN

55343

Change in molding vendors, from in-house production to purchase form an outside vendor.

P990041/S005

3/26/04

Diasorin ETI-AB-EBK PLUS™

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control test of an incoming raw material used in the preparation of Coated Strips of the ETI-AB-EBK PLUS™ which is an in vitro enzyme immunoassay intended for use in the qualitative determination of total antibodies to hepatitis B e antigen in human serum or plasma.

P990043/S006

3/26/04

Diasorin ETI-EBK PLUS™

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control test of an incoming raw material used in the preparation of Coated Strips of the ETI- EBK PLUS™ which is an in vitro enzyme immunoassay intended for use in the qualitative detection of hepatitis B e antigen in human serum or plasma.

P000029/S006

3/1/04

Deflux Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Changes in bioburden test site from an external lab to in-house, an identity test method for a raw material, and specification limits for a raw material.

P000049/S011

3/24/04

CardioSEAL® Septal Occlusion System with Qwik Load

NMT Medical, Inc.

Boston, MA

02210

Change in the manufacturing process of the CardioSEAL® Septal Occlusion System with Qwik Load which involves a change to the bioburden sampling plan to eliminate redundant quarterly testing.

P000053/S003

3/24/04

AMS 800 Urinary Control System

American Medical Systems

Minnetonka, MN

55343

Change in molding vendors, from in-house production to purchase form an outside vendor.

P010020/S001

3/24/04

AMS Acticon Neospnincter

American Medical Systems

Minnetonka, MN

55343

Change in molding vendors, from in-house production to purchase form an outside vendor.

P020003/S002

3/18/04

Saline-Filled Testicular Prostheses

Mentor Corporation

Santa Barbara, CA

93111

Change involving the engraving process, a change in a raw material supplier and a minor change in the molding process.

P020023/S003

3/3/04

Restylane Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Changes in the Restylane raw material, sodium hyaluronate.

P030005/S001

3/3/04

CONTAK RENEWAL TR, Models H120 and H125

Guidant Corporation

St. Paul, MN

55112

Change in the method that is used to release sterilized product, from the use of biological indicators to parametric release.