|
Device | CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROTHESIS,CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICA |
Generic Name | replacement Heart-valve |
Regulation Number | 870.3925 |
Applicant | EDWARDS LIFESCIENCES, LLC. One Edwards Way Irvine, CA 92614 |
PMA Number | P860057 |
Supplement Number | S116 |
Date Received | 11/27/2013 |
Decision Date | 01/24/2014 |
Product Code |
DYE |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL. |