ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S022 · decided 2010-08-13
Approval details
- PMA number
- P990046
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ATS OPEN PIVOT HEART VALVE & ATS OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2010-07-12
- Decision date
- 2010-08-13
- Days to decision
- 32 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR LABELING CHANGES INCLUDING CHANGES TO THE MRI COMPATIBILITY INFORMATION.
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