- Device
- INGEVITY Passive Fixation leads
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S113
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2021-07-14
- Decision code
- OK30
- Date received
- 2021-06-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Simplify the test article used for finished drug product testing such as lot release, stability, and retention for INGEVITY passive fixation leads.