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 | CARPENTIER-EDWARDS(R) PERIMOUNT(TM) BIOPROSTHESIS, MODEL 2700, AND CARPENTIER-EDWARDS(R) PERIMOUNT(TM) RSR BIOPROSTHESIS |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S006 |
Date Received | 11/28/1997 |
Decision Date | 08/26/1998 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for closure of the PMA post-approval study for the Model 2700. |
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