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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.
 
DeviceTriClip™ G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW)
Generic NameTricuspid valve repair device, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP230007
Supplement NumberS019
Date Received11/26/2025
Decision Date02/25/2026
Product Code NPS 
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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