PMA P150012S094
- Device
- INGEVITY lead family
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S094
- Product code
- LWP
- Decision date
- 2020-05-04
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Add a second supplier to supply the pin cap and the sleeve-weld components for the INGEVITY lead family.
Current openFDA PMA Record#
- Device
- INGEVITY lead family
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S094
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-05-04
- Decision code
- OK30
- Date received
- 2020-04-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a second supplier to supply the pin cap and the sleeve-weld components for the INGEVITY lead family.