Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·LIFE PULSE HIGH FREQUENCY VENTILATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA/CONSULTA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOSIGHT READER

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion™ Indirect Decompression System (IDS) Kit, Vertiflex Instrument Platform (VIP) Kit

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERAPY ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY COOL PATH ABLATION CATHETER

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System(SLENDER IDS®), DIRECT Sirolimus-Eluting Coronary Ste

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ID, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Svelte SLENDER® Sirolimus-Eluting Coronary Stent Integrated Delivery System (SLENDER IDS®), Svelte DIRECT Sirolimus-Elut

Biologic Material, Dental

FDA Pre-Market Approval

FDA Class 3 ·Straumann® Emdogain®

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Deep Brain Stimulation Therapy System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ELITE,ELITE II,MINUET,PREVA,PRODIGY,THERA D,THERA DR IPGS, THERA ID PG,THERA IPG,THERA S IPG,THERA SR IPG,THERA VDD IPG,

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICVD, Primo MRI VR ID, Visia AF MRI