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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™ G4 Clip Delivery System
Generic NameTricuspid valve repair device, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP230007
Supplement NumberS008
Date Received10/25/2024
Decision Date11/25/2024
Product Code NPS 
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 implement an automated loading process in the manufacturing of Multi-Lumen Extrusions (MLEs) and a change to deflashing of molded valve components
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