P000054

4/30/04

INFUSE® Bone Graft

Wyeth Pharmaceuticals, Inc.

Philadelphia, PA

19101

Approval for the INFUSE® Bone Graft.  The device is indicated for treating acute, open tibial shaft fractures that have been stabilized with IM nail fixation after appropriate wound management.  INFUSE Bone Graft must be applied within 14 days after the initial fracture.  Prospective patients should be skeletally mature.

P010014

4/21/04

Oxford™ Meniscal Unicompartmental Knee System

Biomet, Inc.

Warsaw, IN

46581

Approval for the Oxford™ Meniscal Unicompartmental Knee System (Phase 3).  The device is indicated for use in patients with osteoarthritis or avascular necrosis limited to the medial compartment of the knee and intended to be implanted with bone cement.

P030017

4/27/04

PRECISION™ Spinal Cord Stimulation (SCS) System

Advanced Bionics

Sylmar, CA

91342

Approval for the PRECISION™ Spinal Cord Stimulation (SCS) System.  The device is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain.

P030023

4/27/04

Oculaid™ Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm), Stableyes™ Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm)

Ophtec USA, Inc.

Boca Raton, FL

33487

Approval for the Oculaid™ Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm), also known as the Stableyes™ Capsular Tension Ring (Model 275 10/12 mm and Model 276 11/13 mm), to be distributed by Advanced Medical Optics.  The device is indicated for the stabilization of weakened, broken or missing zonules that are suspected or observed during cataract extraction using phacoemulsification and continuous curvilinear capsulorhexis techniques in adults.

P030032

4/22/04

Hylaform (hylan B gel)

Genzyme Corp.

Cambridge, MA

01242

Approval for the Hylaform.  The device is indicated for injection into the mid to deep dermis for correction of moderate to severe facial wrinkles and folds (such as nasolabial folds).

P810032/S050

4/29/04

Real-Time

UV-absorbing Multi-Piece PC IOL

Alcon Research Ltd.

Fort Worth, TX

76134

Approval to modify the Indications statement, to indicate the IOLs for use in adult patients following cataract surgery.  Previously, the IOLs were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed.  The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.

P830045/S091

4/9/04

Real-Time

Model 3307 Programmer Software v 4.6m Bradycardia family of devices

St. Jude Medical

Sunnyvale, CA

94086

Approval for the use of tantalum capacitors in Epic™+ VR Model V-196T and Epic™+ DR Model V-239T pulse generators (P910023/S072) and the Model 3307 Programmer Software v 4.6m (P830045/S091 and P880086/S099).  The device, as modified, will be marketed under the trade name Epic™+ VR Model V-196T and Epic™+ DR Model V-239T and Model 3307 Programmer Software v 4.6m.

P840001/S072

4/15/04

Real-Time

Itrel 3®, Synergy™ and Synergy Versitrel™

Medtronic, Inc.

Minneapolis, MN

55432

Approval to use Ealsthane™ resins as alternate materials to Pellethane® resins in leads, extensions and accessories.  The following leads, extensions and accessories will be affected: Model 3487A - Pisces Quad, Model 3887 – Pisces Quad Compact, Model 3888 – Pisces Quad Plus, Model 3890 – Pisces Z Quad, Model 3891 – Pisces Z Quad Compact, Model 3892 – Pisces Z Quad Plus, Model 3898 – Pisces Octad, Model 3998 – Specify, Model 3982A – SymMix, Model 3861 – Temporary Screening Lead, Model 3862 – Verify, Model 3587A – Resume II, Model 3986A ResumeTL, Model 7471 Extension, Model 7489 Extension, Model 7495 Extension, Model 7495LZ Extension, Model 7496 Extension, Model 7498 Extension, Model 3550-09 – Accessory Kit, Model 7441 – Accessory Kit and Model 7441NC – Accessory Kit.

P840060/S028

4/29/04

Real-Time

UV-absorbing Single-Piece PC IOL

Alcon research Ltd.

Fort Worth, TX

76134

Approval to modify the Indications statement, to indicate the IOLs for use in adult patients following cataract surgery.  Previously, the IOLs were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed.  The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.

P850020/S017

4/15/04

Special

PROSORBA® Column

Fresenius Medical Care

Lexington, MA

02420

Approval for labeling changes to 1) add a precaution about the use of pediatric aspirin for rheumatoid arthritis (RA) patients due to the increases risk of thrombosis, and 2) specify the treatment regimen for idiopathic thrombocytopenic purpura (ITP) patients so that patients receive 6 treatments, 2-3 times a week for 2 or 3 weeks.

P850020/S019

4/14/04

180-Day

PROSORBA® Column

Fresenius Medical Care

Lexington, MA

02420

Approval for several changes to the RA-4 post-approval study protocol.  Specifically, these are: 1) a change in inclusion criterion 6 to allow the enrollment of patients who have been on methotrexate (≥ 15 mg/week) for at least three months prior to screening, rather than six months prior to screening; 2) the addition of an inclusion criterion to allow the enrollment of patients who have had toxicity to methotrexate at a dose of ≥ 15 mg/week if they can be on a dose of 12.5 mg/week; 3) the inclusion of patients receiving concomitant treatment with other disease-modifying anti-rheumatic drugs (DMARDs); and 4) the inclusion of patients with 12 or more joints tender or painful on motion or pressure, rather than 16 such joints.

P860004/S058

4/26/04

180-Day

Model 8516 Percutaneous Intraspinal Catheter Kit

Medtronic Neurological

Minneapolis, MN

55432

Approval for the Model 8516 Percutaneous Intraspinal Catheter Kit that is intended to provide access to the epidural or intrathecal space for up to 4 days

P880086/S099

4/9/04

Real-Time

Model 3307 Programmer Software v 4.6m Bradycardia family of devices

St. Jude Medical

Sunnyvale, CA

94086

Approval for the use of tantalum capacitors in Epic™+ VR Model V-196T and Epic™+ DR Model V-239T pulse generators (P910023/S072) and the Model 3307 Programmer Software v 4.6m (P830045/S091 and P880086/S099).  The device, as modified, will be marketed under the trade name Epic™+ VR Model V-196T and Epic™+ DR Model V-239T and Model 3307 Programmer Software v 4.6m.

P880087/S010

4/29/04

Real-Time

UV-absorbing PMMA Single-Piece Anterior Chamber

Alcon Research Ltd.

Fort Worth, TX

76134

Approval to modify the Indications statement, to indicate the IOLs for use in adult patients following cataract surgery.  Previously, the IOLs were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed.  The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.

P900033/S011

4/23/04

Real-Time

Dermal Regeneration Template

Integra LifeSciences Corporation

Plainsboro, NJ

08536

Approval for terminal sterilization of the Dermal Regeneration Template by e-bean sterilization.

P910007/S010

4/28/04

Real-Time

Abbott ARCHITECT® Total PSA Assay

Abbott Laboratories

Abbott Park, IL

60064

Approval for the Abbott ARCHITECT® Total PSA Assay to be used on the ARCHITECT® i2000_SR platform, a member of the ARCHITECT® i2000 instrument family.  The device, as modified, will be marketed under the same trade name ARCHITECT® Total PSA Assay and is indicated:  The ARCHITECT® Total PSA assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of total PSA (both free PSA and PSA complexed to alpha-1-antichymotrypsin [PSA-ACT]) in human serum:  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.  Prostatic biopsy is required for diagnosis of cancer.  2) as an adjunctive test to aid in the management of prostate cancer patients.

P910023/S072

4/9/04

Real-Time

Epic™+ VR Model V-196T and Epic™+ DR Model V-239T

St. Jude Medical

Sunnyvale, CA

94086

Approval for the use of tantalum capacitors in Epic™+ VR Model V-196T and Epic™+ DR Model V-239T pulse generators (P910023/S072) and the Model 3307 Programmer Software v 4.6m (P830045/S091 and P880086/S099).  The device, as modified, will be marketed under the trade name Epic™+ VR Model V-196T and Epic™+ DR Model V-239T and Model 3307 Programmer Software v 4.6m.

P930014/S014

4/29/04

Real-Time

AcrySof UV-absorbing Acrylic Foldable Posterior Chamber (PC) Intraocular lens (IOL)

Alcon Research Ltd.

Fort Worth, TX

76134

Approval to modify the Indications statement, to indicate the IOLs for use in adult patients following cataract surgery.  Previously, the IOLs were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed.  The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.

P930038/S039

4/30/04

Special

Angio-Seal™ Vascular Closure Device STS Platform and Angio-Seal™ Vascular Closure Device STS PLUS Platform

St. Jude Medical, Inc.

Minnetonka, MN

55345

Approval to add language that instructs the user in the method associated with repuncture of the same location of previous Angio-Seal use when the previous use occurred in less than or equal to 90 days.

P950022/S018

4/21/04

Real-Time

Riata defibrillation lead family (Models 1560, 1561, 1562, 1590, 1591 and 1592)

St. Jude Medical

Cardiac Rhythm Management Division

Sunnyvale, CA

94086

Approval for modification to the Riata defibrillation lead family to include integrated bipolar leads (Models 1560, 1561, 1562, 1590, 1591 and 1592).

P960043S053

4/22/04

Special

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

Abbott Vascular Devices

Redwood City, CA

94063

Approval for revised instructions for use, intended to enhance the safe use of the device.

P970003/S051

4/29/04

180-Day

NeuroCybernetic Prosthesis (NCP®) System

Cyberonics, Inc.

Houston, TX

77058

Approval for an alternative sterilization process (hydrogen peroxide gas plasma using the STERRAD 200 GMP Sterilizer) for the Model 302 Lead and Model 502 Accessory Pack and approval for a three year shelf life for the Model 302 Lead and Model 502 Accessory Pack.

P970015/S026

4/16/04

Special

LT Cage PEEK Lumbar Tapered Fusion Device

Sofamor Danek USA

Memphis, TN

38132

Approval of the elimination of the reaming step in the surgical implantation procedures for the LT Cage PEEK Lumbar Tapered Fusion Device, the LT Cage Lumber Tapered Fusion Device, and the INFUSE Bone Graft/LT Cage Lumbar Tapered Fusion Device.

P970015/S027

4/16/04

Special

LT Cage Lumber Tapered Fusion Device

Approval of the elimination of the reaming step in the surgical implantation procedures for the LT Cage PEEK Lumbar Tapered Fusion Device, the LT Cage Lumber Tapered Fusion Device, and the INFUSE Bone Graft/LT Cage Lumbar Tapered Fusion Device.

P970058/S019

4/7/04

Real-Time

ImageChecker M5000D and M5000DM, (Software version 5.2)

R2 Technology, Inc.

Sunnyvale, CA

94087

Approval for the use of the ImageChecker system with the Hologic Selenia full field digital mammographic system and equivalent private label devices.  The device, as modified, will be marketed under the trade names ImageChecker  M5000D (digital mammography only) and ImageChecker M5000DM (digital and analog mammography).  The modified device would be supported by software version 5.2.  The indications for use are: The ImageChecker M5000D/DM is a computer system intended to identify and mark regions of interest on routine screening mammograms to bring them to the attention of the radiologist after the initial reading has been completed.  Thus, the system assists the radiologist in minimizing observational oversights by identifying areas on the original mammogram that may warrant a second review.

P980007/S001

4/15/04

180-Day

Abbott AxSYM Free PSA

Abbott Laboratories

Abbott Park, IL

60064

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

P980016/S042

4/8/04

180-Day

Medtronic Model 7278 Maximo DR Dual Chamber Implantable Cardioverter Defibrillator and Model 7232 Maximo VR Single Chamber Implantable Cardioverter Defibrillator Systems; Model 9978 and Model 9979 (Maximo DR and Maximo VR)

Medtronic, Inc.

Minneapolis, MN

55432

Approval for a manufacturing site located at Medtronic MedRel, Juncos, Puerto Rico.

P980049/S014

4/15/04

Real-Time

Alto 2 DR Model 624 and Alto 2 VR Model 625

ELA Medical, Inc.

Plymouth, MN

55441

Approval for the modifications to the Alto 2 shock module.

P980050/S015

4/12/04

Real-Time

Medtronic GEM III AT with APP, Device Model 7276 and Software Model 9974

Medtronic, Inc.

Minneapolis, MN

55432

Approval for the Medtronic GEM III AT with APP, Device Model 7276 and Software Model 9974.  The device is indicated as follows: The Model 7276 GEM III AT with APP is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias.  The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.  In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory atrial fibrillation, and/or life threatening ventricular tachyarrhythmias.  Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP) and Post Mode Switch Overdrive (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and one or more of the above ICD indications.  Notes: The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias.  The effectiveness of high frequency burst pacing  (Atrial-50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied.  The effectiveness of high frequency burst pacing (Atrial-50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to be 18.2%, in the AF-only patient population studied.

P000009/S011

4/22/04

Real-Time

Tachos Implantable Cardioverter Defibrillator Systems and Programmer Software version A-K00.1.U/5

BIOTRONIK, Inc.

Lake Oswego, OR

97035

Approval for the Automatic Battery Management feature for the Tachos Family Implantable Cardioverter Defibrillator Systems and Programmer Software version a-K00.1.U/5.

P000043/S007

4/28/04

180-Day

TMx-2000™ BPH Thermotherapy System

TherMatrx, Inc.

Northbrook, IL

60062

Approval for a design change for the Rx-200 applicator from a 2.5 cm coil to a 2.0 cm coil.

P000058/S008

4/16/04

Special

INFUSE Bone Graft/LT Cage Lumbar Tapered Fusion Device

Sofamor Danek USA

Memphis, TN

38132

Approval of the elimination of the reaming step in the surgical implantation procedures for the LT Cage PEEK Lumbar Tapered Fusion Device, the LT Cage Lumber Tapered Fusion Device, and the INFUSE Bone Graft/LT Cage Lumbar Tapered Fusion Device.

P010032/S010

4/15/04

Real-Time

Genesis Neurostimulation (IPG) System

Advanced Neuromodulation Systems, Inc.

Plano, TX

75024

Approval for the use of the C-Series Lamitrode Spinal Cord Stimulation Leads, model numbers 3245 (Lamitrode 44C) and 3289 (Lamitrode 88C) for use with the ANS Genesis Neurostimlation (IPG) Model 3608, the ANS Genesis XP Neurostimulation (IPG) Model 3609, the ANS Genesis Dual XP Neurostimulation (IPG) Model 3644 and the ANS Genesis G4 Neurostimulation (IPG) Model 3604 which are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.

P010068/S003

4/2/04

180-Day

Navistar DS Diagnostic/Ablation Deflectable Tip Catheters

Biosense Webster, Inc.

Diamond Bar, CA

91765

Approval for a manufacturing site located at Biosense Webster, Inc., Juarez, Mexico.

P020014/S007

4/8/04

180-Day

Conceptus Essure™ System for Permanent Birth Control

Conceptus, Inc.

San Carlos, CA

94070

Approval for a manufacturing site located at Venusa, Ltd., Chihuahua, Mexico.

P020018/S003

4/15/04

180-Day

Zenith® FLEX™ AAA Endovascular Graft and H&L-B One-Shot™ Introduction System

Cook Incorporated

Bloomington, IN

74702

Approval to increase the stent spacing (from 0-3 mm to 5 ± 1mm) on the main body and the main body extension components of the Zenith® AAA Endovascular Graft.

P020045/S001

4/13/04

180-Day

7F Freezor™ Cardiac CryoAblation Catheter and CCT.2 CryoConsole System

Applied Physics

Brookline, MA

02445

Approval of the post-approval study for the device.

P030006/S001

4/15/04

180-Day

Prolieve™ Thermodilatation System

Celsion Corporation

Columbia, MD

21046

Approval of the post-approval study for the device.

P930038/S038

4/8/04

Angio-Seal™ Vascular Closure Device

St. Jude Medical

Minnetonka, MN

55345

Change to include an additional vendor.

P940040/S003

4/22/04

AMPLICOR® Mycobacterium tuberculosis (MTB) Test

Roche Molecular Systems, Inc.

Pleasanton, CA

94566

Change to the manufacturing process of the device to incorporate a terminal 0.2um filtration step to the Avidin-Horseradish Peroxidase (HRP) BGG Conjugate reagent manufacturing process to ensure the removal of adventitious agents remaining in the reagent following formulation.

P990038/S007

4/30/04

DiaSorin ETI-MAK-2-PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control specifications related to the Positive Control OD and concentration limits for kit and component release.

P990041/S006

4/30/04

DiaSorin ETI-AB-EBK PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming raw materials.

P990042/S007

4/30/04

DiaSorin ETI-AB-AUK PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming raw materials.

P990043/S007

4/30/04

DiaSorin ETI-EBK PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming raw materials.

P990044/S005

4/30/04

DiaSorin ETI-CORE-IGMK PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming raw materials.

P990045/S006

4/30/04

DiaSorin ETI-AB-COREK PLUS

DiaSorin, Inc.

Stillwater, MN

55082

Change in the quality control tests used to determine specific attributes of incoming raw materials.

P000006/S004

4/28/04

Mentor Inflatable Penile Prosthesis

Mentor Corporation

Santa Barbara, CA

93111

Change in the raw material supplier of a chemical used in the manufacturing of Mentor’s Inflatable Penile Prosthesis.

P000029/S007

4/21/04

Deflux® Injectable Gel

Q-Med Scandinavia, Inc.

Princeton, NJ

08540

Changes to the accessory device, the Deflux metal needle, to include addition of bioburden and sterility testing and to remove the bioindicator usage during ordinary manufacturing.

P030019/S003

4/9/04

Orthovisc® High Molecular Weight Hyaluronan

Anika Therapeutics, Inc.

Woburn, MA

01801

Additional process control step used in the production of Orthovisc® High Molecular Weight Hyaluronan.

P030024/S001

4/2/04

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

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14626

Replacement of key equipment used in performing the Coated Well test Procedure and the acceptance criteria associated with its use.  In addition, the coated well sampling plan, randomization methods for sampling, and test error correction methods have been improved to further ensure batch quality and reduction of production waste for the manufacture of the coated microwells.