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 | Biocor, Biocor Supra, Epic, Epic Supra Valves |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P040021 |
Supplement Number | S037 |
Date Received | 10/24/2018 |
Decision Date | 01/17/2019 |
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 the replacement of nylon suture with polyester suture for certain areas of construction of the Biocor and Epic heart valves. |
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