PMA P150012S098
- Device
- ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S098
- Product code
- LWP
- Decision date
- 2020-09-03
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add instructions, images, and an inspection for preforming battery cathode tabs.
Current openFDA PMA Record#
- Device
- ESSENTIO, PROPONENT, ACCOLADE - MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S098
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-09-03
- Decision code
- OK30
- Date received
- 2020-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add instructions, images, and an inspection for preforming battery cathode tabs.