PMA supplement
P220024 S004: LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
FDA PMA supplement · Real-Time Process · Advanced Medical Solutions Limited
Key facts
| Original PMA | P220024 |
|---|---|
| Supplement number | S004 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device |
| Generic name | Tissue adhesive internal use |
| Applicant | Advanced Medical Solutions Limited |
| Product code | PLJ |
| Received date | Sep 15, 2023 |
| Decision date | Dec 14, 2023 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: