Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Ventak PRx and Ventak Mini AICDs

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RIATA/RIATA ST & DURATA FAMILIES OF LEADS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRIS XT DR/XT VR/S DR/S VR SureScan, Visia AF MRI XT and S VR SureScan, Primo MRI SureScan and Mirro MRI SureScan

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

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 PHARMDX

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK 1550 PULSE GENERATOR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Protecta ICD, Protecta VR, XT ICD and Secura ICD, Secura DR ICD

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 ·ENDOTAK FAMILY INCLUDES ENDOTAK, ENDOTAK ENDURANCE, ENDOTAK RELIANCE

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DIVA FAMILY, SELECTION AFM C-SERIES AND T-SERIES DEVICES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, MOMENTUM EL ICD VR, MOMENTUM EL ICD DR, VIGILANT EL ICD VR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Epicardial Patch Lead

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

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

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Evera MRI: DF-1 ICD, ICD; Evera S: DR ICD, VR ICD; Evera XT, DR ICD, VR ICD; Mirro MRI: DR ICD, VR ICD; Primo MRI: DR IC

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·PD-L1 IHC 22C3 pharmDx

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Fortify Assura , Ellipse

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (Non-CRT)

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NG3 Implantable Cardioverter Defibrillators (ICDs), NG4 ICDs