Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DA+ C-SERIES AND DA+ T-SERIES

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MICRA TRANSCATHETER PACING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF CONDUCTR 5 MM (7FR, 8FR TIP), RF CONDUCTR 4 MM (7FR), RF CONTACTR 5 MM (7FR, 8FR TIP), RF CONTACTR 5 MM (7FR, 8FR TIP

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA VERSA, SENSIA IPG, ADVISA DR IPG, ADVISA DR MRI IPG, RELIA IPG.

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Epicardial Pacing Lead

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Attain Bipolar OTW Lead, OTW LV Lead; Serena, Solara Quadripolar CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900/RELIA/SIGMA/MEDTRONIC 350/ENPULSE/ENRHYTHM/AT500/ADAPTA/VERSA/SENSIA IPGS

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 ·Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Serena Bipolar/ Quadrip