PMA P150012S051
- Device
- Essentio MRI, Proponent MRI, Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S051
- Product code
- LWP
- Decision date
- 2018-02-02
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for labeling updates to the pulse generator replacement guide.
Current openFDA PMA Record#
- Device
- Essentio MRI, Proponent MRI, Accolade MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S051
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-02-02
- Decision code
- APPR
- Date received
- 2017-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for labeling updates to the pulse generator replacement guide.