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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMITRACLIP DELIVERY SYSTEM
Classification Namemitral valve repair devices
ApplicantABBOTT VASCULAR INC.
PMA NumberP100009
Date Received03/04/2010
Decision Date10/24/2013
Product Code
NKM[ Registered Establishments with NKM ]
Docket Number 13M-1365
Notice Date 11/15/2013
Advisory Committee Cardiovascular
Clinical Trials NCT00209274
NCT00209339
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mitraclip clip delivery system (mitraclip cds). This device is indicated for the percutaneous reduction of significant 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
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S002 
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