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 | 3F AORTIC BIOPROSTHESIS, MODEL 1000 |
Generic Name | heart-valve, non-allograft tissue |
Applicant | MEDTRONIC Inc. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS, MN 55432 |
PMA Number | P060025 |
Supplement Number | S012 |
Date Received | 07/09/2013 |
Decision Date | 10/02/2013 |
Withdrawal Date
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10/26/2016 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE TO THE PACKAGING SYSTEM FOR THE 3F AORTICBIOPROSTHESIS, MODEL 1000. |
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