Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
FDA premarket approval P990046/S056 · decided 2020-03-20
Approval details
- PMA number
- P990046
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Open Pivot Heart Valves and Open Pivot Aortic Valved Graft
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2020-02-20
- Decision date
- 2020-03-20
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Modification to the manufacturing in-process inspection acceptance criteria for percent silicon weight of pyrolytic carbon coated orifices and leaflets.
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