- Device
- INGEVITY™ MRI/ model 7731; INGEVITY™ MRI/ model 7732; INGEVITY™ MRI/ model 7735; INGEVITY™ MRI/ model 7736; INGEVITY™ MR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S179
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-02-13
- Decision code
- OK30
- Date received
- 2026-01-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- qualifying an alternate supplier for outer tray packaging