OPEN PIVOT HEART VALVE
FDA premarket approval P990046/S036 · decided 2013-10-09
Approval details
- PMA number
- P990046
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- OPEN PIVOT HEART VALVE
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2013-09-10
- Decision date
- 2013-10-09
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- NEW PIECE OF EQUIPMENT INTENDED FOR AUTOMATED INSPECTION OF THE MECHANICAL VALVE SUBASSEMBLY.
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