Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

FDA Pre-Market Approval

FDA Class 3 ·Freestyle Libre Flash Glucose Monitoring System

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DISCOVERY & MERIDIAN PULSE GENERATORS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·REGENT, STANDARD AND MASTERS MECHANICAL HEART VALVE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·ITREL II, ITREL 3, SYNERGY AND SYNERGY VERSITREL NEUROSTIMULATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA ICDM INSYNC III MARQUIS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD, PRODIGY IPG, SERVICE KIT-PACEMAKER REPAIR KIT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SELECTSECURE LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, IMPULSE II LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ACE HEADER, END CAP, SIZING SLEEVE, , UPSIZING SLEEVE

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ADHESIVE, CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELENCE PS+LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON C20 SR IPG , C60 DR IPG, T20 SR IPG, VITATRON T60 DR IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TRANSVENE LEAD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Y ADAPTOR/EXTENDER KIT, DF-1 CONNECTOR POT PIN PLUG, HV SPLITTER/ADAPTOR KIT, IS-I CONNECTOR PORT PIN PLUG KIT,

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX MRI LEAD, REVO MRI IPG

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN BIPOLAR OTW LEAD, CONSULTA CRT-P, LEFT VENTRICULAR PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, S VR ICD,XT DR ICD, XT VR ICD, INTRINISIC ICD, MARQUIS DR ICD, VR ICD, MAXIMO DR ICD, MAXIMO II ICD; VR