Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECUSION SPINAL CORD STIMULATOR (SCS) SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Genus Deep Brain Stimulation (DBS) System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION MONTAGE MRI SPINAL CORD STIMULATOR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) System- (Precision Spectra, Spectra WaveWriter, Precision Novi, Precision Montage

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise PC and Vercise Gevia Deep Brain Stimulation (DBS) Systems

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICE ORIGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD INOGEN VR DF4, VR DF1/IS1, DR DF4/IS1, DR DF1/IS1, ICD DYNAGE

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

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN CRT-D DF4/IS1, ICD INOGEN CRT-D DF/IS1/IS1, ICD INOGEN CRT-D DF1/IS1/IS4, ICD INOGEN CRT-D DF4/IS1/IS4, ICD D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD BG1 TN STR MRI IS1, LD BG1 TN J MRI IS1, LD BG1 PFRET STR MRI IS1, LD INGEVITY PLUS AF IS1

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

FDA Pre-Market Approval

FDA Class 3 ·ID/SN Label

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN VR DF4, ICD INOGEN VR DF1/IS1, ICD INOGEN DR DF4/IS1, ICD INOGEN DR DF1/IS1, ICD DYNAGEN VR DF1/IS1, ICD DYNA

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING STENT SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EASYTRAK 3 IS-1 LEADS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·ACUITY STEERABLE IS-1 LEADS

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·LIFEPAK FLEX™ Lithium-ion Battery

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE IS-1 LEAD

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LD Ingevity Plus AF IS1