OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
FDA premarket approval P990046/S035 · decided 2013-08-07
Approval details
- PMA number
- P990046
- Supplement
- S035
- Supplement type
- 30-Day Notice
- Trade name
- OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT
- Generic name
- HEART-VALVE, MECHANICAL
- Applicant
- Medtronic Ats Medical, Inc.
- Date received
- 2013-07-08
- Decision date
- 2013-08-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWQ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- REVIEW OF: 1) INSTALLATION QUALIFICATION (IQ) REPORTS FOR 4 PIECES OF EQUIPMENTRELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT; AND 2) ONE PROCESS QUALIFICATION (PQ) REPORT FOR ONE PIECE OF EQUIPMENT RELATED TO AN ALREADY APPROVED SITE CHANGE SUPPLEMENT. THESE CHANGES APPLY TO THE OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVED GRAFT.
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