Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System, Supera Pro Interwoven Peripheral Stent System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DIVA PLATFORM IMPLANTABLE PULSE GENERATORS & PRO VIT APPLICATION SOFTWARE

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·PRO OSTEON IMPLANT 500 POROUS CORALLINE HYDROXYAPATITE BONE GRAFT SUBSTITUTE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve System, CoreValve Evolut R System, CoreValve Evolut PRO System

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance and Arctic Front Pro Catheters Shaft Components

Filler, Bone Void, Non-Osteoinduction

FDA Pre-Market Approval

FDA Class 3 ·INTERPORE PRO OSTEON IMPLANT 500 CORALLINE HYDROXYAPATITE BONE VOID FILLER

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·CORDIS PRECISE/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·Artic Front Advance and Artic Front Advance Pro Cryoablation Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EnVeo Rand EnVeo PRO Delivery Catheter System of the CoreValve

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Visi-Pro™ Balloon-Expandable Peripheral Stent System, lntraStent™ DoubleStrut™ Stent

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS KRO,KR10,KBO,KB10,OF10,OB10,KN10,NB10 LENS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PRECISE OTW/PRECISE RX/PRECISE PRO RX NITINOL STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro Cryoablation Catheter

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Core Valve Evolut R System and Core Valve Evolut PRO System

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Fron Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·IntraStent DoubleStrut Stent; Visi-Pro Balloon-Expandable Peripheral Stent System (Ilac)

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance and Arctic Front Advance Pro Cardiac CryoAblation Catheters

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

FDA Pre-Market Approval

FDA Class 3 ·Arctic Front Advance Pro and Arctic Front Advance Cardiac Cryoablation Catheters

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System