Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

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, Relia IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·REVO MRI SURESCAN PACING SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX/CAPSUREFIX NOVUS/SUREFIX/VITATRON CRYSTALLINE ACTFIX/VITATRON PIROUET S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO II DR/VR ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA,ADAPTA L,ADAPTA S,SENSIA L,SENSIA,VERSA IPG,ADVISA DR IPG,ENRHYTHM IPG,RELIA,SIGMA DR IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS LEAD, VITATRON EXCELLENCE PS+ LEAD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG,ENRHYTHM IPG,SIGMA DR AND SIGMA S IPG,ADVISA DR MRI IPG

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPICARDIAL PACING LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPACE DATA COLLECTOR AND NIKON ROUTER

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP NOVUS/Z NOVUS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P, Syncra CRT-P, Viva CRT-P

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·En Trust ICD, Intrinsic ICD, Marquis DR & VR ICD, Maximo II DR ICD, Maximo II ICD, Maximo VR ICD, Protecta ICD /XT ICD,

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

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE LEAD; CAPSURE SP NOVUS LEAD; VITATRON CYRSTALLINE LEAD; VITATRON EXCELLENCE PS+ LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System (TPS)

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II