PMA P220024S001

Device: LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Applicant: Advanced Medical Solutions Limited
PMA number: P220024
Supplement: S001
Product code: PLJ
Decision date: 2023-07-28
Classification: General, Plastic Surgery
Generic name: Tissue adhesive internal use
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.

Current openFDA PMA Record#

Device: LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
Applicant: Advanced Medical Solutions Limited
PMA number: P220024
Supplement: S001
Product code: PLJ
Generic name: Tissue adhesive internal use
Decision date: 2023-07-28
Decision code: APPR
Date received: 2023-06-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
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.