PMA P010012S594

Device: Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425,
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S594
Product code: NIK
Decision date: 2026-04-21
Classification: Cardiovascular
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for updates to a communications module and associated product circuit board (PCB) components in ICD and CRT-D families of devices.

Current openFDA PMA Record#

Device: Cardiac Resynchronization Therapy Defibrillators (CRT-D) RESONATE: G524, G525, G526, G528, G537, G547, G548, G424, G425,
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S594
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-04-21
Decision code: APPR
Date received: 2025-08-13
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for updates to a communications module and associated product circuit board (PCB) components in ICD and CRT-D families of devices.