PMA P150012S119
- Device
- ESSENTIO™ MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT™ MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S119
- 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™ MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT™ MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S119
- 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.