PMA P150012S034
- Device
- ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S034
- Product code
- LWP
- Decision date
- 2017-09-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
Current openFDA PMA Record#
- Device
- ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S034
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-09-21
- Decision code
- APPR
- Date received
- 2017-07-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material