Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II DR/VR

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

FDA Pre-Market Approval

FDA Class 3 ·LIAISON® XL MUREX HBsAg Qual and LIAISON® XL MUREX Control HBsAg Qual

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Master IntellisTM and VantaTM Spinal Cord Stimulation Systems

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD 2 Lead, Servuce Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACILITAXEL-ELUTING CORONARY STENT SYSTEM (MONORAIL)

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD IIIAC PREMOUNTED STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM.

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE LEAD, 4073, CAPSURE SENSE UNIPOLAR LEAD, CAPSURE BIPOLAR LEAD, VITATRON CRYSTALINE LEAD, VITATRON CRYSTALI

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK P2 ICD FAMILIES

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Revo MRI SureScan IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit and Vitatron Brilliant S+ VDD Lead

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Element Everolimus-Eluting Platinum Chromium Coronary Stent System, Promus Premier Everolimus-Eluting Platinum Ch

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MODEL 2901 PROGRAMMER

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA/VERSA/SENSIA/RELIA/ENRHYTHM IPGS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR