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510(k) for LiquiBand
510(k) for LiquiBand.
About this update from Advanced Medical Solutions Group Plc
[{"type":"text","content":"\n RNS Number : 4835N Advanced Medical Solutions Grp PLC 18 February 2009 \n \n\n\n\n\nFor Immediate Release \n\n\n18 February 2009\n\n\n\n\n\nAdvanced Medical Solutions Group plc \n('AMS' or 'the Company')\n\n510(k) clearance for LiquiBand™ Topical Skin Adhesive\n\nWinsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global medical technology company, today announces that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for one of its LiquiBand™ Topical Skin Adhesive formulations.\n\nThe US market constitutes the major part of the global topical tissue adhesives market, which has an estimated value of $200 million annually. AMS' commercial strategy has therefore been focused on obtaining US approval for a product range that is already sold successfully in Europe. \n\nIn May 2008, following review of a petition submitted on behalf of AMS' MedLogic Wound Closure Division, the FDA concluded that tissue adhesives for topical approximation of skin should be reclassified from Class III to Class II. This meant that these devices will now be cleared for commercial distribution via a Pre-Market Notification 510(k) submission rather than a Pre-Market Approval (PMA) application. AMS has subsequently submitted 510(k) applications covering its tissue adhesive product range.\n\nThe initial product cleared for sale by the FDA, LiquiBand™ Topical Skin Adhesive, is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma induced lacerations in areas of low skin tension that are simple, thoroughly cleansed and have easily approximated edges.\n\nThis particular product has been sold successfully for many years in Europe and has allowed AMS to establish a leadership position in the use of tissue adhesives for closing wounds in the Accident & Emergency (A&E) arena.\n\nClearance is also being sought for additional products that will provide a comprehensive range of topical skin adhesives covering both the A&E and Operating Room mar...