Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·DIMENSION FPSA FLEX REAGENT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead and Transvene CS/SVC L

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,Astra X

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Azure XT SR / DR MRI SureScan, Azure S SR / S DR MRI SureScan , Software Model

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC III CRT-P

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,

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS, Micra TPS, Micra VR TPS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·Myocardial Pacing Lead

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MODEL 8040 PULSE GENERATOR

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, Relia IPG

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-P, SYNCRA CRT-P AND VIVA CRT-P

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·IS-1 Plug, Sprint Quattro Secure S MRI SureScan Lead, Sprint Quattro Secure MRI SureScan and Sprint Quattro MRI SureScan

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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