Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC KAPPA 700/600 SERIES

FDA Pre-Market Approval

MEDTRONIC SIGMA/MEDTRONIC 350 SERIES PULSE GENERATORS PRODUCTS

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DEMA IPG/DDDR/CLARITY SSIR/DIAMOND III/RUBY III/TOPAZ III/JADE III/VITA 2 DDDR

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Attain StarFix Model 4195 Lead

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF ENHANCR II, RF MARINR 7FR, RF MARINR 5FR, RF MARINR UNIPOLAR, RF CONTACTR, RF CONDUCTR

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSYNC CRT-P

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·RF Marinr Catheters

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·4965 EPICARDIAL LEAD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS, Micra VR TPS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT DR MRI IPG, Astra S DR MRI IPG, Astra S SR 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 ·Advisa MRI DR /SR SureScan Implantable Pulse Generators (IPGs)

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 ·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,

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 COnnector Port Pin Plug Kit, Lead Ad

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra Transcatheter Pacing System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA SR MRI