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Biotime Inc receives FDA premarket notification clearance for Premvia(tm) 510(k)

Tuesday, 12 Aug 2014 09:00am EDT 

Biotime Inc:Received notice from FDA's Center for Devices and Radiologic Health that Premvia (tm) has been cleared for marketing as Class II medical device.Premvia (tm)( )is first FDA-cleared member of BioTime's HyStem ( (reg) )family of hydrogels, which are designed to mimic the natural structures of human body's extracellular matrix.According to FDA clearance, product is indicated for management of wounds including: partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers.It also includes chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds. 

Company Quote

-0.01 -0.29%
27 Nov 2015