Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·Ventana PD-L1 (SP142) Assay

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMOS VR-T AND LUMOS DR-T IMPLANTABLE CARDIOVERTER DEFIBRILLATORS WITH 502.U ICS PROGRAMMER SOFTWARE, A-K00.4.U EPR/...

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP142) Assay

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST ICD, INTRINSIC 30 ICD, INTRINSIC ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO VR IC

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spectra, Precision Novi, Precision Montage, Precision Montage MRI an Spectra WaveWriter SPinal Cord Stimulator

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

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV AND LV-T PULSE GENERATORS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CYLOS FAMILY OF PULSE GENERATORS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX FAMILY OF ICDS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HIRESOLUTION BIONIC EAR SYSTEM (HIRES 90K)

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEW 3 RF

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SECURA & MAXIMO II ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC CONSULTA & MAXIMO ICDS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·RELIATY/MODEL 3145 PACING SYSTEM ANALYZER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·D010 INOGEN MINI ICD VR, D011 INOGEN MINI ICD VR, D012 INOGEN MINI ICD DR, D013 INOGEN MINI ICD DR, D020 DYNAGEN MINI IC

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1(SP142) CDX ASSAY