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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 NumberS004
Date Received09/15/2023
Decision Date12/14/2023
Product Code PLJ 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an extension to the shelf life from 18 to 24 months.
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