- Device
- PG ESSENTIO SR, PG ESSENTIO DR, PG PROPONENT SR, PG PROPONENT DR, PG ACCOLADE SR, PG ACCOLADE DR, PG ALTRUA 2 SR, PG ALT
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S256
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocate several manufacturing steps for Tachy, Brady, and S-ICD's.