INGEVITY Passive Fixation leads
FDA premarket approval P150012/S113 · decided 2021-07-14
Approval details
- PMA number
- P150012
- Supplement
- S113
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY Passive Fixation leads
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-06-16
- Decision date
- 2021-07-14
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Simplify the test article used for finished drug product testing such as lot release, stability, and retention for INGEVITY passive fixation leads.
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