OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
FDA premarket approval P990046/S041 · decided 2016-02-08
Approval details
- PMA number
- P990046
- Supplement
- S041
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2015-08-10
- Decision date
- 2016-02-08
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for modification to in-process inspection.
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