FDA.reportPublic FDA data

Cardiac resynchronization therapy implantable defibrillator

Definition
An implantable, battery-powered device consisting of a hermetically-sealed pacing pulse generator and an integrated defibrillation pulse generator with leads in the right ventricle, in a coronary vein over the left ventricle, and often in the right atrium (triple chamber). In addition to conventional pacing and defibrillation functions, the device is intended to provide cardiac resynchronization therapy (CRT) through biventricular electrical stimulation to synchronize right and left ventricular contractions for more effective blood pumping to treat symptoms of heart failure (e.g., shortness of breath, easy fatigue) and serious heart-rhythm problems [CRT defibrillator (CRT-D)].
GUDID devices
29
Last updated
2026-10-04 01:13:55

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00763000059651Viva™ Quad XT CRT-DMEDTRONIC, INC.DTBA1QQ2017-10-21
00763000059668Viva™ XT CRT-DMEDTRONIC, INC.DTBA1D42017-10-21
04035479182809Acticor Sky HF-T QPBIOTRONIK SE & Co. KG4819852026-04-20
04035479182816Acticor Sky HF-TBIOTRONIK SE & Co. KG4819862026-04-20
04035479182854Rivacor Sky HF-T QPBIOTRONIK SE & Co. KG4819902026-04-20
04035479182861Rivacor Sky HF-TBIOTRONIK SE & Co. KG4819912026-04-20
04035479182984Rivacor Aura HF-T QPBIOTRONIK SE & Co. KG4820122026-04-20
04035479182991Rivacor Aura HF-TBIOTRONIK SE & Co. KG4820132026-04-20
04035479183028Rivacor Rise HF-T QPBIOTRONIK SE & Co. KG7820162026-04-20
04035479183035Rivacor Rise HF-TBIOTRONIK SE & Co. KG4820172026-04-20
05414734502214Promote®ST. JUDE MEDICAL, INC.3107-302014-10-24
05414734502252Promote®ST. JUDE MEDICAL, INC.RF2014-10-24
05415067050045Neutrino™ST. JUDE MEDICAL, INC.CDHFA600D2025-02-11
05415067050052Gallant™ST. JUDE MEDICAL, INC.CDHFA500D2025-02-11
05415067050076Neutrino™ST. JUDE MEDICAL, INC.CDHFA600B2025-02-11
05415067050090Gallant™ST. JUDE MEDICAL, INC.CDHFA500B2025-02-11
05415067050106Entrant™ST. JUDE MEDICAL, INC.CDHFA300B2025-02-11
05415067050120Entrant™ST. JUDE MEDICAL, INC.CDHFA300D2025-02-11
05415067049513Entrant™ST. JUDE MEDICAL, INC.CDHFA300T2024-04-25
05415067049520Gallant™ST. JUDE MEDICAL, INC.CDHFA500T2024-04-25
00802526589744RESONATE™ HF CRT-DBOSTON SCIENTIFIC CORPORATIONG5472021-07-12
00763000178178Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.DTPB2QQ2020-06-08
00763000178185Cobalt™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.DTPB2Q12020-06-08
00763000178215Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.DTPB2D42020-06-08
00763000178222Cobalt™ HF CRT-D MRI SureScan™MEDTRONIC, INC.DTPB2D12020-06-08
00763000178253Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.DTPC2QQ2020-06-08
00763000178260Crome™ HF Quad CRT-D MRI SureScan™MEDTRONIC, INC.DTPC2Q12020-06-08
00763000178291Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.DTPC2D42020-06-08
00763000178307Crome™ HF CRT-D MRI SureScan™MEDTRONIC, INC.DTPC2D12020-06-08