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 PERIMOUNT MAGNA MITRAL EASE PERCARDIAL BIOPRSTHESIS MODELS 7300 AND 7300TFX |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S068 |
Date Received | 04/26/2010 |
Decision Date | 06/24/2010 |
Product Code |
DYE |
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 NEW MITRAL VALVE MODEL TO BE ADDED TO THE CARPENTIER-EDWARDS PERIMOUNT VALVE SERIES, WHICH INCORPORATES A NEW SUTURE GUIDE LINE, A HYBRID CLIP, A MODIFIED JAR, A MODIFIED SLEEVE, A HYBRID HOLDER, AND MODIFIED ACCESSORIES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESES, MODELS 7300 & 7300TFX, AND IS INDICATED FOR PATIENTS WHO REQUIRE REPLACEMENT OF THEIR NATIVE OR PROSTHETIC MITRAL VALVE. |
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