Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT(TM)

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·HEALON DUET DUAL PACK

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·VISCOAT, DUOVISC & DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SYNCRA CRT-P, CONSULTA CRT-P, INSYNC CRT-P, INSYNC III CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA, AT500, ENRHYTHM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST, INSTRINSIC, MARQUIS, SECURA, VARIOUS MODELS OF MAXIMO, PROTECTA, & VIRTUOSO

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EPIC VASCULAR SELF-EXPANDING STENT SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Precise Nitinol Stent Systems

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·DRIVER & MICRO-DRIVER CORONARY STENT SYSTEMS

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. Control Nitinol Stent System

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·IN.PACT Admiral Paclitaxel-Coated Balloon Catheter

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·S.M.A.R.T. and S.M.A.R.T. Control Vascular Stent Systems

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS ILIAC

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS TIPS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·Enroute Transcarotid Stent System