Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SECURA DR/VR, VIRTUOSO II DR/VR AND MAXIMO II DR/VR

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

FDA Pre-Market Approval

FDA Class 3 ·CONSULTA CRT-D, CONCERTO II CRT-D AND MAXIMO II CRT-D

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T, EVIA HF/HF-T, ENTOVIS HF/HF-T CRT-P'S

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

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IFORIA/ILESTO 5/7 DR-T/VR-T/VR-T DX/HF-T; KRONOS LV-T, VARIOUS LUMAX MODELS CRT-D'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS DR-T,DR,SR-T,SR; ELUNA 8 DR-T PROMRI,DR PROMRI,SR-T PRMRI,SR PROMRI;SETROX S53,S60;SAFIO S53,S60

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·KRONOS LV-T CRT-D

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX IMPLANTABLE CARDIOVERTER DIFIBRILLATOR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC

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 IC

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340/500/540 DR/DR-T/VR/VR-T/KRONOS LV-T/LUMAX 300/340/500/540 HF/HF-T

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

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·BELOS & LEXOS DR/DR-T/VR/VR-T/LUMOS DR-T/VR-T/XELOS DR-T

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ACTROS & AXIOS & KAIROS DR/SR/SLR/D/S/BA03 DDDR/CYLOS DR/DR-T/VR/DOMOS DR/SR/SL/PHILOS&PHILOS II DR/DR-T/SR/SLR/D/S/PROT

Immunohistochemistry Assay, Antibody, Programmed Death-Ligand 1

FDA Pre-Market Approval

FDA Class 3 ·VENTANA PD-L1 (SP263) ASSAY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ENTOVIS, EVIA, ESTELLA, EFFECTA, ECURO, DEXTRUS, SETROX, SELOX, TILDA, P-KIT, SAFIO, SLX, CARDIOMESSENGER LLT KIT, ICS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA MRI