Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LVAS SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC VASCULAR ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY, IDENTITY, INTEGRITY & VICTORY/ZEPHYR FAMILY OF DEVICES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CARBON TIP CARDIAC PACING LEAD

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·cobas HPV Test

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProGlide Suture-Mediated Closure System

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

FDA Pre-Market Approval

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

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Perclose ProStyle Suture-Mediated Closue and Repair System

Somatic Gene Mutation Detection System

FDA Pre-Market Approval

FDA Class 3 ·LeukoStrat CDx FLT3 Mutation Assay

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (Zephyr Valve)

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cobas HPV Test

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus Bioprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Supera Peripheral Stent System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FreeStyle Libre Pro Flash Glucose Monitoring System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AQUAFLEX HYDROPHILIC CONTACT LENSES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock II Bioprosthesis

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STYLE 17 & 17A POSTERIOR CHAMBER IOLS