Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve AP360
FDA premarket approval P990046/S065 · decided 2022-10-21
Approval details
- PMA number
- P990046
- Supplement
- S065
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Open Pivot Heart Valve, Open Pivot Aortic Valved Graft, Open Pivot Heart Valve AP360
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2022-09-26
- Decision date
- 2022-10-21
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Implementation of updated equipment used in the orifice core (graphite mold) removal process.
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