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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMITRACLIP DELIVERY SYSTEM
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 County Road B East
St. Paul, MN 55117
PMA NumberP100009
Date Received03/04/2010
Decision Date10/24/2013
Product Code NKM 
Docket Number 13M-1365
Notice Date 11/15/2013
Advisory Committee Cardiovascular
Clinical TrialsNCT00209274
Expedited Review Granted? Yes
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow 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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