PMA P150012S053
- Device
- ESSENTIO; PROPONENT; ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S053
- Product code
- LWP
- Decision date
- 2018-02-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- New controlled environment area (CEA) level VIII for battery testing.
Current openFDA PMA Record#
- Device
- ESSENTIO; PROPONENT; ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S053
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-02-08
- Decision code
- OK30
- Date received
- 2018-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- New controlled environment area (CEA) level VIII for battery testing.