OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S027 · decided 2012-04-03
Approval details
- PMA number
- P990046
- Supplement
- S027
- Supplement type
- Special (Immediate Track)
- Trade name
- OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2012-03-08
- Decision date
- 2012-04-03
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR ADDING TEXT TO THE OPEN PIVOT AORTIC VALVED GRAFT INSTRUCTIONS FOR USE (IFU) TO STRENGTHEN THE CAUTERIZATION PRECAUTION STATEMENT.
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