- Device
- ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2 (Models S701,
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S311
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-10-03
- Decision code
- OK30
- Date received
- 2026-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement an additional acceptance activity for Accolade SL batteries and to change a specification for an existing Accolade EL battery specification