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Device | CARPENTIER-EDWARDS PERIMOUNT MAGNA BIOPROSTHESES MODELS 3000 AND 3000TFX |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S041 |
Date Received | 10/27/2006 |
Decision Date | 02/13/2007 |
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 MANUFACTURING PROCESS ENHANCEMENT FOR THE CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS MODELS 3000 AND 3000TFX POLYESTER BAND/ELGILOY BAND SUB-ASSEMBLY JOINING TECHNIQUE CONSISTING OF SEWING THROUGH ALL OF THE BAND HOLES. |