PMA P150012S004
- Device
- INGENIO 2 MRI PACEMAKERS.
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S004
- Product code
- LWP
- Decision date
- 2016-07-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for design changes to the accelerometer component and associated changes.
Current openFDA PMA Record#
- Device
- INGENIO 2 MRI PACEMAKERS.
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S004
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-07-14
- Decision code
- APPR
- Date received
- 2016-05-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design changes to the accelerometer component and associated changes.