- Device
- ALTRUA 2, ESSENTIO, PROPONENT, and ACCOLADE
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S258
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-11-16
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.