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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™ G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW)
Generic NameMitral valve repair devices
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP100009
Supplement NumberS082
Date Received11/26/2025
Decision Date02/25/2026
Product Code NKM 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for minor design changes to the clip locking mechanism in the implant and to the delivery system handle of the MitraClip G5 and TriClip G5 Delivery Systems.
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