- Device
- PG ACCOLADE DR, PG ACCOLADE SR, PG ALTRUA 2 DR, PG ALTRUA 2 SR, PG ESSENTIO DR, PG ESSENTIO SR, PG PROPONENT DR, and PG
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S257
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-10-22
- Decision code
- OK30
- Date received
- 2020-10-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the inspection criteria, cycle duration, brush life, and gowning requirements for the automated de-burring process of pulse generator case halves.