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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 NumberS005
Date Received05/01/2014
Decision Date05/22/2014
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A LABELING CHANGE THAT INCLUDED ADDITIONS TO THE LIST OF ANTICIPATED EVENTS AND CONVERTING CERTAIN PROCEDURAL CAUTION STATEMENTS TO WARNING STATEMENTS.
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