- Device
- ESSENTIO SR, ESSENTIO DR, PROPONENT SR, PROPONENT DR, ACCOLADE SR, ACCOLADE DR, ALTRUA 2 DR, ALTRUA 2 SR
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S268
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-09-24
- Decision code
- OK30
- Date received
- 2021-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the adhesive and liner used on the tray label stock for pulse generators and Leads.