PMA N970003S269
- Device
- ESSENTIO™ SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT™ SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE™ SR; ACCOLADE DR; ACC
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S269
- Product code
- LWP
- Decision date
- 2021-10-21
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Automate a battery component cleaning process.
Current openFDA PMA Record#
- Device
- ESSENTIO™ SR; ESSENTIO DR; ESSENTIO EL DR; PROPONENT™ SR; PROPONENT DR; PROPONENT EL DR; ACCOLADE™ SR; ACCOLADE DR; ACC
- Applicant
- Boston Scientific Corp
- PMA number
- N970003
- Supplement
- S269
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-10-21
- Decision code
- OK30
- Date received
- 2021-10-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automate a battery component cleaning process.