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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 Delivery System
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS079
Date Received07/21/2025
Decision Date08/18/2025
Product Code NKM 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
to change the incoming inspection sampling plan for components of the TriClip and MitraClip Delivery Systems from an Attribute Acceptable Quality Limit (AQL) to a variable-based plan with custom sampling plan requirements
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