INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742
FDA premarket approval P150012/S031 · decided 2017-07-27
Approval details
- PMA number
- P150012
- Supplement
- S031
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INGEVITY MRI models: 7731, 7732, 7735, 7736, 7740, 7741, 7742
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-05-01
- Decision date
- 2017-07-27
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a change in the raw material on the proximal electrode assembly of INGEVITY MRI lead models.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.