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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceLIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Generic NameTissue adhesive internal use
ApplicantAdvanced Medical Solutions Limited
Western Wood Way, Langage Science Park
Plympton, Plymouth PL7 5
PMA NumberP220024
Date Received10/27/2022
Decision Date06/02/2023
Product Code PLJ 
Docket Number 23M-2807
Notice Date 07/28/2023
Advisory Committee General & Plastic Surgery
Clinical TrialsNCT04009213
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for The LIQUIFIX FIX8 Hernia Mesh Fixation device is intended for use in laparoscopic surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall and the approximation of the peritoneum.The LIQUIFIX Precision Open Hernia Mesh Fixation device is intended for use in open surgical repair of groin (inguinal and femoral) hernias, achieved through the fixation of prosthetic polypropylene or polyester mesh to the abdominal wall.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S004 
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