PMA P150012S110
- Device
- ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S110
- Product code
- LWP
- Decision date
- 2021-05-06
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Remove dwells from laser weld process.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT, ACCOLADE MRI SR, ACCOLADE MRI DR, ACCOLADE MRI EL DR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S110
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-05-06
- Decision code
- OK30
- Date received
- 2021-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Remove dwells from laser weld process.