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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 G4 System
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 Country Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS063
Date Received01/16/2024
Decision Date02/14/2024
Product Code NKM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
a manufacturing location change of a component supplier and a change to the electropolishing process of the CDS Clip Arm components from a manual to an automated process
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