- Device
- ESSENTIO™ SR, ESSENTIO™ DR, ESSENTIO™ EL DR, PROPONENT™ SR, PROPONENT™ DR, PROPONENT™ EL DR, ACCOLADE™ SR, ACCOLADE™ DR
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S272
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-12-21
- Decision code
- OK30
- Date received
- 2021-12-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add alternate nitrile gloves to be used in the manufacturing operations at BSC-Clonmel.