Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICONE AND PMMA INTRAOCULAR LENSES AND OCUCOAT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER(TM) ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS (IOL)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·MOSAIC PORCINE BIOPROSTHESIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINTY/IDENTITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS RX MULTI-LINK HP/ACS OTW MULTI LINK HP CORONARY STENT SYSTEM

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 28-8 pharmDx

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MOSIAC PORCINE BIOPROSTHESIS

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT ADMIRAL PACLITAXEL-COATED PERCUTANEOUS ANGIOPLASTY BALLOON CATHETER

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Fortify; Fortify Assura

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Novi Spinal Cord Stimulator (SCS) System Flash Memory Component Update

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSORS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM & STERILE CABLES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RESOLUTE MICROTRAC/RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Access Hybritech PSA

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Low Porosity Valved Conduit