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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.
 
DeviceLIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Generic NameTissue adhesive internal use
Regulation Number878.4010
ApplicantAdvanced Medical Solutions Limited
Western Wood Way
Langage Science Park
Plymouth PL7 5BG
PMA NumberP220024
Supplement NumberS001
Date Received06/30/2023
Decision Date07/28/2023
Product Code PLJ 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220024.
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