PMA P220024

Device: LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Applicant: Advanced Medical Solutions Limited
Product code: PLJ
Decision date: 2026-01-14
Generic name: Tissue adhesive internal use
Approval order statement: approval of the revised protocol to enhance enrollment of the LIQUFIX Post-Approval Study (PAS). The changes are, namely, revising the enrollment milestone dates. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220024.

Current openFDA PMA Record#

Device: LIQUIFIX FIX8 Hernia Mesh Fixation (HMF) Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Applicant: Advanced Medical Solutions Limited
PMA number: P220024
Supplement: S005
Product code: PLJ
Generic name: Tissue adhesive internal use
Decision date: 2026-01-14
Decision code: APPR
Date received: 2025-10-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol to enhance enrollment of the LIQUFIX Post-Approval Study (PAS). The changes are, namely, revising the enrollment milestone dates. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P220024.