Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | OPEN PIVOT HEART VALVE AND OPEN PIVOT AORTIC VALVE GRAFT |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S035 |
Date Received | 07/08/2013 |
Decision Date | 08/07/2013 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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