Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)
FDA premarket approval P990046/S062 · decided 2022-03-10
Approval details
- PMA number
- P990046
- Supplement
- S062
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Open Pivot Mechanical Valve (OPHV), Open Pivot Aortic Valved Graft (AVG)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2022-02-08
- Decision date
- 2022-03-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- New yarn extrusion and compounding suppliers and automation of the scouring process for the polyester yarn components.
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