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Device | CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL 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 | S056 |
Date Received | 05/01/2009 |
Decision Date | 07/09/2009 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW DEVICE TRADE NAME AND MODEL NUMBER TO ADD TO THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS FAMILY. MODEL 7200TFX IS IDENTICAL TO THE PREVIOUSLY APPROVED MODEL 7000TFX WITH THE EXCEPTION OF A DIFFERENT SIZING CONVENTION. THERE ARE NO CHANGES TO THE DIMENSIONS OF THE DEVICE OR THE INDICATIONS FOR USE. THE DEVICE AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESISMODEL 7200TFX AND IS INDICATED FOR THE REPLACEMENT OF MALFUNCTIONING NATIVE OR PROSTHETIC MITRAL VALVES. |