OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360
FDA premarket approval P990046/S044 · decided 2015-12-16
Approval details
- PMA number
- P990046
- Supplement
- S044
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE,OPEN PIVOT AORTIC VALVED GRAFT,OPEN PIVOT HEART VALVE-APEX,OPEN PIVOT HEART VALVE-AP360
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2015-11-24
- Decision date
- 2015-12-16
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- TO RELOCATE YOUR FABRIC VENDOR'S MANUFACTURING OPERATIONS TO LA COITAT, FRANCE.
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