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Device | Edwards Pericardial Mitral Bioprosthesis, Model 11000M |
Generic Name | heart-valve, non-allograft tissue |
Applicant | EDWARDS LIFESCIENCES, LLC. ONE EDWARDS WAY IRVINE, CA 92614-5688 |
PMA Number | P150048 |
Supplement Number | S012 |
Date Received | 12/01/2017 |
Decision Date | 08/09/2018 |
Product Code |
LWR |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT01757665
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Edwards Pericardial Mitral Bioprosthesis, Model 11000M. This device is indicated for the replacement of native or prosthetic mitral 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 |