PMA P150012S062
- Device
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S062
- Product code
- LWP
- Decision date
- 2018-07-17
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for an inner tray redesign for the packaging used for the standard life (SL) Accolade pacemakers..
Current openFDA PMA Record#
- Device
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S062
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2018-07-17
- Decision code
- APPR
- Date received
- 2018-05-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for an inner tray redesign for the packaging used for the standard life (SL) Accolade pacemakers..