- Device
- MOMENTUM, MOMENTUM X4, INOGEN, DYNAGEN, VIGILANT, VIGILANT X4, RESONATE, RESONATE X4, RESONATE HF
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S609
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices