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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 NumberS001
Date Received04/19/2024
Decision Date05/09/2024
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  
a manufacturing location change of a component supplier, a change to the electropolishing process of the CDS Clip Arm components from a manual to an automated process, and use of an additional sterilization line, aeration room, and pre-existing preconditioning room to increase sterilization capacity at the currently approved contract sterilization facility
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