PMA P150012S188
- Device
- LD INGEVITY™ PLUS AF
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S188
- Product code
- LWP
- Decision date
- 2026-06-09
- Classification
- Cardiovascular
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- an alternative vapor degreasing solvent used by a supplier, Integer Brooklyn Park
Current openFDA PMA Record#
- Device
- LD INGEVITY™ PLUS AF
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S188
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2026-06-09
- Decision code
- OK30
- Date received
- 2026-05-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative vapor degreasing solvent used by a supplier, Integer Brooklyn Park