OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S034 · decided 2013-07-30
Approval details
- PMA number
- P990046
- Supplement
- S034
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2013-07-01
- Decision date
- 2013-07-30
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR REVISING THE LIST OF POTENTIAL ADVERSE EVENTS IN THE INSTRUCTIONS FOR USE.
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