System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA Endoprosthesis

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·Zilver® Vascular Stent

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim® Therapy System, Verify® Evaluation System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX,SWEET PICOTIP RX,FLEXTEND

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead; Attain OTW LV Lead

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·POLYMACON SOFT (HYDROPHILIC) EXTENDED WEAR CONTACT LENSES

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124

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

FDA Pre-Market Approval

FDA Class 3 ·Intua, Invive, Valitude, and Visionist CRT-Ps

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·Medtronic MiniMed 630G System with Guardian Sensor (3)/ Guardian Sensor (3)

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-PS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Alto Abdominal Stent Graft System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CareLink SmartSync Device Manager Programmer

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System and Verify Evaluation System (SNS Urinary)