|
Device | ST JUDE MEDICAL TRIFECTA VALVE |
Generic Name | heart-valve, non-allograft tissue |
Applicant | Abbott Medical 177 County Road B. East St. Paul, MN 55117 |
PMA Number | P100029 |
Date Received | 07/20/2010 |
Decision Date | 04/20/2011 |
Product Code |
LWR |
Docket Number | 11M-0296 |
Notice Date | 05/06/2011 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00475709
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ST. JUDE MEDICAL TRIFECTA VALVE. THE TRIFECTA VALVE IS INTENDED AS A REPLACEMENT FOR A DISEASED, DAMAGED, OR MALFUNCTIONING NATIVE OR PROSTHETIC AORTIC HEART VALVE. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
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 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 S042 S043 S045 S046 S047 S048 S049 |