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. |
|
Device | CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES, MODELS 7100 AND 7100TFX |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S054 |
Date Received | 12/22/2008 |
Decision Date | 02/20/2009 |
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 MINOR MODIFICATIONS TO THE 3.8 OZ JAR PACKAGING SYSTEM USED FOR THE MODELS 7000 AND 7000TFX, CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL BIOPROSTHESES AND A NEW NAME AND MODEL NUMBER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE MITRAL BIOPROSTHESES MODELS 7100 AND 7100TFX AND ARE INDICATED FOR MITRAL VALVE REPLACEMENT. |
|
|