PMA P150012S137
- Device
- INGEVITY+ and INGEVITY MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S137
- Product code
- LWP
- Decision date
- 2022-12-15
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Update a manufacturing inspection process and add a new manufacturing traceability system.
Current openFDA PMA Record#
- Device
- INGEVITY+ and INGEVITY MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S137
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-12-15
- Decision code
- OK30
- Date received
- 2022-12-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update a manufacturing inspection process and add a new manufacturing traceability system.