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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 country 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
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: S022 S023 S024  S001 S002 S014 S015 S012 S004 S005 S013 
S010 S011 S008 S009 S006 S007 S016 S047 S048 S046 S049 S050 
S042 S017 S018 S019 S020 S021 S025 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S036 S037 S038 S039 S043 S044 S045 
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