OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)
FDA premarket approval P990046/S038 · decided 2014-08-20
Approval details
- PMA number
- P990046
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE (OPHV) AND OPEN PIVOT AORTIC VALVED GRAFT (OPAVG)
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2014-07-25
- Decision date
- 2014-08-20
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- AN ALTERNATE VISION SYSTEM FOR IN-PROCESS INSPECTION OF LEAFLET COMPONENTS.
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