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 | TRIFECTA VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P100029 |
Supplement Number | S011 |
Date Received | 03/22/2012 |
Decision Date | 04/13/2012 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR REVISING THE INSTRUCTION REGARDING ¿SUTURE TAILS¿. |
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