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Device | MITRACLIP DELIVERY SYSTEM |
Generic Name | Mitral valve repair devices |
Applicant | Abbott Medical 177 County Road B East St. Paul, MN 55117 |
PMA Number | P100009 |
Date Received | 03/04/2010 |
Decision Date | 10/24/2013 |
Product Code |
NKM |
Docket Number | 13M-1365 |
Notice Date | 11/15/2013 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00209274
|
Expedited Review Granted? | Yes |
Combination Product | No |
Predetermined Change Control Plan Authorized | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MITRACLIP CLIP DELIVERY SYSTEM (MITRACLIP CDS). THIS DEVICE IS INDICATED FOR THE PERCUTANEOUS REDUCTION OFSIGNIFICANT SYMPTOMATIC MITRAL REGURGITATION (MR >= 3+) DUE TO PRIMARY ABNORMALITY OF THE MITRAL APPARATUS [DEGENERATIVE MR] IN PATIENTS WHO HAVE BEEN DETERMINED TO BE AT PROHIBITIVE RISK FOR MITRAL VALVE SURGERY BY A HEART TEAM, WHICH INCLUDES A CARDIAC SURGEON EXPERIENCED IN MITRAL VALVE SURGERY AND A CARDIOLOGIST EXPERIENCED IN MITRAL VALVE DISEASE, AND IN WHOM EXISTING COMORBIDITIES WOULD NOT PRECLUDE THE EXPECTED BENEFIT FROM REDUCTION OF THE MITRAL REGURGITATION. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S043 S045 S024 S018 S019 S020 S017 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S048 S049 S001 S002 S021 S022 S023 S025 S030 S036 S029 S037 S053 S054 S057 S065 S068 S069 S063 S026 S027 S032 S033 S034 S035 S028 S031 S039 S050 S055 S046 S047 S042 S044 S038 S051 S052 S070 S058 S059 S060 S061 S067 S064 S071 S072 S073 S074 S062 S066 S056
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