OPEN PIVOT BI-LEAFLET HEART VALVE
FDA premarket approval P990046/S019 · decided 2009-04-24
Approval details
- PMA number
- P990046
- Supplement
- S019
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- OPEN PIVOT BI-LEAFLET HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2008-09-26
- Decision date
- 2009-04-24
- Days to decision
- 210 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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