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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 System (NTR and XTR)
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 County Rd. B E.
St.Paul, MN 55117
PMA NumberP100009
Supplement NumberS025
Date Received10/24/2017
Decision Date05/23/2018
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for several design and manufacturing changes to the clip delivery system and implant as well as minor changes to device packaging.
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