OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S043 · decided 2015-12-16
Approval details
- PMA number
- P990046
- Supplement
- S043
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2015-11-16
- Decision date
- 2015-12-16
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- A CHANGE TO THE BIOBURDEN MONITORING STRATEGY AND STERILITY VERIFICATION DOSE MONITORING.
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