Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

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

FDA Pre-Market Approval

FDA Class 3 ·R3 ACETABULAR SHELLS

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Comfilcon A Soft (Hydrophilic) contact lenses for extended wear

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Pure Vision (balafilcon A) Visibility Tinted Soft (hydrophillic) Contact Lens

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK® CR2 Defibrillator

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·PATHVYSION HER-2 DNA PROBE KIT

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Paragon Z CRT (tisilfocon A) Rigid Gas Permeable Contact Lenses in Blue Tint

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS Therapy System; Model 3100 Programming Software; Model 2000 Programming Wand

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® and S.M.A.R.T.® Vascular Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF INTRAOCULAR LENSES

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIBAHN ENDOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEMS

System, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection

FDA Pre-Market Approval

FDA Class 3 ·Cologuard

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+/PULSAR COCHLEAR IMPLANT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·COOPERVISION METHAFILCON AB EXTENDED WEAR CONTACT LENSES

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Ranger Paclitaxel-Coated Balloon Catheter

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Cordis® S.M.A.R.T.® CONTROL® Vascular Stent System