Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·BVI 1% OVD-SODIUM HYALURONATE VISCOELASTIC

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY, ATTAIN ABILITY PLUS & ATTAIN ABILITY STRAIGHT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE CS/SVC LEAD

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX CORONARY STENT SYSTEM (MONORAIL)

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II VENTRICULAR ASSISTE SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·INTERFACE CABLES

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEMS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/PROTECTA XT/ICD/SECURA/VIRTUOSO II

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR SPRINT ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PureVision (balafilcon A) Visibility Tinted Contact Lens

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI ICD / Evera S DR / S VR /XT DR / XT VR ICD; Visia AF MRI VR ICD / Visia AF VR ICD

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGICELTM Family of Absorbable Hemostats

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber and Defibrillator, automatic

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine Dermal Filler, RADIESSE® (+) Jawline

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P