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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMITRACLIP CLIP DELIVERY SYSTEM
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 Country Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS002
Date Received11/26/2013
Decision Date01/28/2014
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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