PMA P150012S128
- Device
- Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S128
- Product code
- LWP
- Decision date
- 2022-07-25
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Addition of a filter for use during manufacturing of the INGEVITY family of lead devices.
Current openFDA PMA Record#
- Device
- Ingevity MRI pace/sense lead, Ingevity+ MRI pace/sense lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S128
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2022-07-25
- Decision code
- OK30
- Date received
- 2022-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a filter for use during manufacturing of the INGEVITY family of lead devices.