Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·DF-1 Connector Port Pin Plug, HV Splitter/Adopter Kit, Sprint Quattro Lead

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera, Mirro, Primo, Protecta, Secura, Visia, S DR, VR XT DF1 MRI ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) PRX II/III AICD SYSTEM AND IS-1/DF-1 LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ilivia Neo 7 VR-T, Intica Neo 7 VR-T DX, Plexa ProMRI DF-1 S DX 65/17, Plexa ProMRI DF-1 S DX 65/15, Plexa ProMRI S 60,

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·LINOX SMART S65,LINOX SMART SD 65/18,LINOX S DX 65/15,LINOX S DX 65/17,PROTEGO DF-1 S 65,PROTEGO DF-1 SD 65/18,PROTEGO D

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

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

FDA Pre-Market Approval

CONCERTO II CRT-D, CONSULTA DF4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D

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 ·ADVISA DR IPG, ADVISA MRI IPG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Avant™, Neutrino™ NxT, Gallant™, and Entrant™ (NGQ) ICDs and CRT-Ds DF-1 Model Expansion

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SPRINT QUATTRO SECURE S SINGLE COIL IS-1/DF-1, ACTIVE FIX LEAD MODEL 6935

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI XT DR SureScan ICD DDMB1D1, Evera MRI XT VR SureScan ICD DVMB1D1, Evera MRI S DR SureScan ICD DDMC3D1, Evera M

ACCELOGRAPH

FDA 510(k)

FDA Class 2 ·Anesthesiology

TOF-GUARD TRANSMISSION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

AM 706 ELECTROMYOGRAPH, STIM., NEURO., EXTERNAL

FDA 510(k)

FDA Class 2 ·Physical Medicine

MINI ACCELOGRAPH NEUROMUSCULAR TRANS. MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology

ACCELOGRAPH NEUROMUSCULAR TRANSMISSION MONITOR

FDA 510(k)

FDA Class 2 ·Anesthesiology