- Device
- INOGEN, DYNAGEN, MOMENTUM, VIGILANT EL, PERCIVA MINI, RESONATE EL, PERCIVA HF, RESONATE HF
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S514
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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