Pulse-Generator, Single Chamber, Single

FDA Pre-Market Approval

FDA Class 3 ·INTERTACH TM IMPLANTABLE PACEMAKER PULSE

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HEMOSTAGENE(R) ABSORBABLE COLL. HEMOSTATIC SPONGE

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·EXCIMED(TM) UV200LA LASER SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE TIGRIS VASCULAR STENT

Catheter, Balloon For Retinal Reattachment

FDA Pre-Market Approval

FDA Class 3 ·GRIESHABER SCLERAL BUCKLING BALLOON CATHETER

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·3M BRAND COCHLEAR IMPLANT SYSTEM/HOUSE DESIGN

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIPLOS MODEL 05 A & B

Pump, Drug Administration, Closed Loop

FDA Pre-Market Approval

FDA Class 3 ·GENESA(R) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AFP

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·PAPNET (R) TESTING SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INTRA COIL SELF-EXPANDING PERIPHERAL STENT

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Catheter, Percutaneous, Long Term, Intraspinal

FDA Pre-Market Approval

FDA Class 3 ·PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYSTEM

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·INTERGEL ADHESION PREVENTION SOLUTION

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CIRCULAR OPEN LOOP POSTERIOR IOLS & KRATZ ELLIPTIC

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·AXSYM HBSAG, HBSAG CONFIRMATORY, AND AXSYM HBSAG CONTROLS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLES 31-34 POSTERIOR IOLS