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 | ATS OPEN PIVOT BILEAFLET HEART VALVE |
Generic Name | HEART-VALVE, MECHANICAL |
Applicant | MEDTRONIC ATS MEDICAL, INC. 3800 ANNAPOLIS LANE, SUITE 175 PLYMOUTH, MN 55447 |
PMA Number | P990046 |
Supplement Number | S001 |
Date Received | 10/17/2000 |
Decision Date | 05/10/2001 |
Product Code |
LWQ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR VALVE SIZES 16/19 MM AORTIC AND 24/27 MM MITRAL AND THE ADDITION OF A VALVE RESTERILIZATION INSTRUCTION IN THE LABELING. |
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