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LIQUIFIX FIX8 Laparoscopic Hernia Mesh Fixation Device, LIQUIFIX Precision Open Hernia Mesh Fixation Device

FDA premarket approval P220024/S001 · decided 2023-07-28

Approval details

PMA number
P220024
Supplement
S001
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
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
2023-06-30
Decision date
2023-07-28
Days to decision
28 days
Decision code
APPR
Product code
PLJ
Advisory committee
General, Plastic Surgery
Expedited review
No
Location
Plymouth
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.

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510(k) clearances by this applicant

RecordFirmDate
Antimicrobial Silicone PHMB Foam Wound Dressing (K223310)Advanced Medical Solutions Limited2023-04-05
LiquiBand XL (K211878)Advanced Medical Solutions Limited2022-05-23
LiquiBand Plus (K183570)Advanced Medical Solutions Limited2020-03-09
SILVER ANTIMICROBIAL WOUND GEL (K110458)Advanced Medical Solutions Limited2011-03-14
SILVER PU ANTIBACTERIAL FOAM DRESSING - NON ADHERENT AND ISLAND (K091013)Advanced Medical Solutions Limited2009-07-30
SILVER ALGINATE 11 WOUND DRESSING (K090453)Advanced Medical Solutions Limited2009-02-26
SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING (K080503)Advanced Medical Solutions Limited2008-11-12
NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING (K081363)Advanced Medical Solutions Limited2008-09-24