PMA P150012S031
- Device
- INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S031
- Product code
- LWP
- Decision date
- 2017-07-27
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for a change in the raw material on the proximal electrode assembly of INGEVITY MRI lead models.
Current openFDA PMA Record#
- Device
- INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S031
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-07-27
- Decision code
- APPR
- Date received
- 2017-05-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a change in the raw material on the proximal electrode assembly of INGEVITY MRI lead models.