PMA P150012S013
- Device
- Essentio, Proponent and Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S013
- Product code
- LWP
- Decision date
- 2016-10-04
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for an alternate capacitor in the medical implant communication service module component.
Current openFDA PMA Record#
- Device
- Essentio, Proponent and Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S013
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-10-04
- Decision code
- APPR
- Date received
- 2016-07-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an alternate capacitor in the medical implant communication service module component.