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Device | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614-5688 |
PMA Number | P150048 |
Date Received | 12/28/2015 |
Decision Date | 06/29/2017 |
Product Code |
LWR |
Docket Number | 17M-3990 |
Notice Date | 07/06/2017 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01757665
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve. The Edwards Pericardial Aortic Bioprosthesis, Model 11000A, is indicated for the replacement of native or prosthetic aortic heart valves. The Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, is indicated for the replacement of native or prosthetic aortic heart valves. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S034 S035 S036 S037 S038 S039 S040 S041 S042 S043 S044 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 S067 S068 S069 S071 S072 S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 |