Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Flash Glucose Monitoring System

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Exact System

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·CardioGenesis TMR System

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·ORTHOPAK(R) BONE GROWTH STIMULATOR

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMO(R) VITRAX(R) VISCOELASTIC SOLUTION

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 400

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·BIOTRON PARVOVIRUS B19 IGM ENZYME IMMUNOASSAY

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING PC INTRAOCULAR LENS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold With Metal Prosthesis, Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INFUSE BONE GRAFT/LT-CAGE LUMAR TAPERED FUSION DEVICE

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·PROVISC OPHTHALMIC VISCOSURGICAL DEVICE

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEMS (MONORAIL & OVER-THE-WIRE)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ARTEFILL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETER AND IBI 1500T CARDIAC ABLATION GENERATOR

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

FDA Pre-Market Approval

FDA Class 3 ·MONOLISA ANTI-HBS EIA AND MONOLISA ANTI-HBS CALIBRATOR KIT

Intraocular Lens

FDA Pre-Market Approval

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