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Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·PRECISION SPECTRA SPINAL CORD STIMULATOR (SCS) SYSTEM

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·FLEXTOME CUTTINGG BALLOON DILATATION DEVICE

Sensor, Glucose, Invasive

FDA Pre-Market Approval
FDA Class 3 ·DEXCOM SEVEN PLUS SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval
FDA Class 3 ·EPIC HF FAMILY CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval
FDA Class 3 ·CADENCE ICDS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·LOTRAFILCON A AND LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval
FDA Class 3 ·EDWARDS NOVAFLEX+ DELIVERY SYSTEM

Stent, Iliac

FDA Pre-Market Approval
FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® Nitinol Stent Systems, Cordis® S.M.A.R.T.® and S.M.A.R.T.® CONTROL® Vascular Stent Systems,

Stent, Coronary

FDA Pre-Market Approval
FDA Class 3 ·EXPRESS CORONARY STENT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval
FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval
FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval
FDA Class 3 ·STAAR SURGICAL COLLAMER UV-ABSORBING POSTERIOR CHAMBER

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

FDA Pre-Market Approval
FDA Class 3 ·CERAMTEC CERAMIC TRANSCEND HIP ARTICULATION SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval
FDA Class 3 ·VISTAKON (SENOFILCON A) BRAND CONTACT LENSES

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval
FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETERS

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval
FDA Class 3 ·SCS ACCESSORIES,SCS 1X8 EXTENSION,SCS QUADRIPOLAR EXTENSION,SCS LEADS SPECIFY FAMILY,SCS LEADS 1X8 FAMILY,SCS LEADS

Lens, Multifocal Intraocular

FDA Pre-Market Approval
FDA Class 3 ·ACRYSOF RESTOR INTRAOCULAR LENSES

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval
FDA Class 3 ·PATH VYSION HER-2 DNA PROBE KIT

Device, Hemostasis, Vascular

FDA Pre-Market Approval
FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM