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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 System
Generic NameMitral valve repair devices
ApplicantAbbott Medical
177 Country Road B East
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS038
Date Received01/25/2021
Decision Date02/22/2021
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  
Minor manufacturing changes to the gripper line of the Clip Delivery System.
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