MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED
FDA premarket approval P990046/S029 · decided 2012-06-25
Approval details
- PMA number
- P990046
- Supplement
- S029
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- MEDTRONIC OPEN PIVOT BILEAFLET HEART VALVED
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2012-04-26
- Decision date
- 2012-06-25
- Days to decision
- 60 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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