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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 System
Generic NameTricuspid valve repair device, percutaneously delivered
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP230007
Supplement NumberS020
Date Received02/06/2026
Decision Date03/06/2026
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  
harmonization across preconditioning parameters in preconditioning cells at one sterilization facility, and implementation of sustainable reduced ethylene oxide sterilization cycles at two other sterilization facilities
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