Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

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

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova™ Vascular Self-Expanding Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve™ EnVeo™ R Delivery Catheter System, CoreValve™ EnVeo™ PRO Delivery Catheter System, Evolut™ PRO+ Delivery Cath

Stimulator, Carotid Sinus Nerve

FDA Pre-Market Approval

FDA Class 3 ·BAROSTIM NEO® System

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·SynchroMed Infusion System, Ascenda Intrathecal Catheters

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA DR/VR/PROTECTA XT DR/VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·JEWEL AF MODEL 7250

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE, VALITUDE X4 CRT-PS

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON - TB Gold Plus and LIAISON XL Control QuantiFERON-TB Gold Plus

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACCOLADE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SWEET TIP RX, SWEET PICOTIP RX, AND FLEXTEND LEAD SYSTEM FAMILIES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II, BLAZER II HTD, BLAZER PRIME HTD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DYNAGEN CRT-D, INOGEN CRT-D, ORIGEN CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE FIX MRI LEAD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces, Specify, and Vectris Spinal Cord Stimulation Lea

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator™and ROTAPRO™ Rotational Atherectomy System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT EASY-TRACK 2 LEADS