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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL ICDS/CRT-DS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MyCareLink Firmware

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/C& T SERIES IPGS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·INSYNC II PROTECT ICD, IIIMARQUIS ICD, MARQUIS ICD, MAXIMO ICD, BRAVA CRT-D, CONCERTO ICD, II CRT-D, CONSULTA ICD, MAXIM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta/Versa/Sensia, Advisa DR/DR MRI/SR MRI, EnPulse E1/E2, Kappa DR (Kappa 700/600, 900/800)/VDD (Kappa 700) families

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, ADAPTA L, ADAPTA S, SENSIA L, SENSIA VERSA IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·KAPPA 600/700/650/800/900 FAMILIES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·WRENCH KIT/SERVICE KIT/CAPSURE VDD LEADS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE FAMILY OF ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SOLUS,ADDVENT,SOLUS II,SYNCHRONY, PHOENIX III, TRIOLOGY, AFFINITY, INTEGRITY, ENTITY,IDENTITY, VERITY, AND VICTORY PACEM