- Device
- Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S186
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-06-03
- Decision code
- OK30
- Date received
- 2026-05-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of a new controlled environment area (CEA) at the Boston Scientific Dorado, Puerto Rico facility