PMA P960040S507

Device: Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120,
Applicant: Boston Scientific
PMA number: P960040
Supplement: S507
Product code: LWS
Decision date: 2026-04-21
Classification: Cardiovascular
Generic name: Implantable cardioverter defibrillator (non-CRT)
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: Implantable Cardioverter Defibrillators (ICD) RESONATE: D420, D421, D432, D433, D520, D521, D532, D533; MOMENTUM: D120,
Applicant: Boston Scientific
PMA number: P960040
Supplement: S507
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.