PMA P150012
- Device
- INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S138
- Product code
- LWP
- Decision date
- 2026-05-19
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- a new rework process to de-adhere suture sleeve from lead body
Current openFDA PMA Record#
- Device
- INGEVITY™ MRI; INGEVITY™+; INGEVITY™+ Passive
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S184
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-05-19
- Decision code
- OK30
- Date received
- 2026-04-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a new rework process to de-adhere suture sleeve from lead body