PMA P150012S123
- Device
- INGEVITY MRI pace/sense lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S123
- Product code
- LWP
- Decision date
- 2022-03-08
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add sterilization chamber equipment to the Dorado, Puerto Rico manufacturing facility.
Current openFDA PMA Record#
- Device
- INGEVITY MRI pace/sense lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S123
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-03-08
- Decision code
- OK30
- Date received
- 2022-02-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add sterilization chamber equipment to the Dorado, Puerto Rico manufacturing facility.