LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device
FDA premarket approval P220024/S004 · decided 2023-12-14
Approval details
- PMA number
- P220024
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- 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
- Date received
- 2023-09-15
- Decision date
- 2023-12-14
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PLJ
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Plymouth
- Statement
- Approval for an extension to the shelf life from 18 to 24 months.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Antimicrobial Silicone PHMB Foam Wound Dressing (K223310) | Advanced Medical Solutions Limited | 2023-04-05 |
| LiquiBand XL (K211878) | Advanced Medical Solutions Limited | 2022-05-23 |
| LiquiBand Plus (K183570) | Advanced Medical Solutions Limited | 2020-03-09 |
| SILVER ANTIMICROBIAL WOUND GEL (K110458) | Advanced Medical Solutions Limited | 2011-03-14 |
| SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013) | Advanced Medical Solutions Limited | 2009-07-30 |
| SILVER ALGINATE 11 WOUND DRESSING (K090453) | Advanced Medical Solutions Limited | 2009-02-26 |
| SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503) | Advanced Medical Solutions Limited | 2008-11-12 |
| NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363) | Advanced Medical Solutions Limited | 2008-09-24 |