OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT
FDA premarket approval P990046/S028 · decided 2013-06-28
Approval details
- PMA number
- P990046
- Supplement
- S028
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE & OPEN PIVOTAORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2012-03-23
- Decision date
- 2013-06-28
- Days to decision
- 462 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED IN MINNEAPOLIS, MINNESOTA.
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