- Device
- ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321)
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S305
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2025-12-17
- Decision code
- OK30
- Date received
- 2025-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a new acceptance activity and associated equipment for extended life (EL) pacemaker and CRT-P batteries