Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS, LINOX S/T/SD/TD, KENTROX SL-S/RV-S/SL/RV STEROID, LINOX(SMART) ST/TD LEADS

Assay,Enzyme Linked Immunosorbent,Parvovirus B19 Igm

FDA Pre-Market Approval

FDA Class 3 ·Parvovirus B19 IgM Enzyme Immunoassay (V619IMUS)

Mr-Guided Focused Ultrasound System

FDA Pre-Market Approval

FDA Class 3 ·ExAblate Neuro Thalamotomy

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (Zephyr Valve)

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System

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

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS 8MM DIAGNOSTIC/ABLATION TIP CATHETER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SJM PACEMAKERS

Agent, Bulking, Injectable For Gastro-Urology Use

FDA Pre-Market Approval

FDA Class 3 ·Coaptite

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·Alinity i Anti-HBc lgM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Single-Piece PMMA Posterior Chamber IOL

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·Minitouch 3.8 Era System (Minitouch System)

Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions

FDA Pre-Market Approval

FDA Class 3 ·GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETERS

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Catheter and HeartLight Console

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT (DERMAL FILLERS)

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM