Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix MRI Lead

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DA+C & VITATRON DA+T SERIES IPGS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·SUREFIX LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG/Attesta IPG/Relia IPG/Sphera IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE, VITATRON CRYSTALINE, & VITATRON EXCELLENCE PS+

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·2490C CARELINK MONITOR

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN STARFIX MODEL 4195 LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,VERSA ,SENSIA IPG, ADVISA DR IPG.ADVISA DR MRI IPG,ENPULSE E1 IPG,ENPULSE E2 IPG, ENRHYTHM IPG,KAPPA D(KAPPA 700)

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS-SWISS DOLORCLAST

Generator, Shock-Wave, For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·EMS SWISS DOLORCLAST