Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K134037
    Device Name
    PREMVIA
    Manufacturer
    Date Cleared
    2014-08-07

    (219 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    BIOTIME, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Premvia is indicated for the management of wounds including: partial thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, postlaser surgery, podiatric wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.
    Device Description
    Premvia™ is a wound matrix supplied in a package containing sterile 3 lyophilized vials and 1 vial of sterile reconstitution solution. Premvia™ is a resorbable, viscoelastic hydrogel matrix that consists of modified glycosaminoglycan and collagen molecules that crosslink upon reconstitution and combination of the three sterile, lyophilized components: thiolmodified hyaluronan, thiol-modified gelatin, and polyethylene glycol diacrylate (Extralink). To create the hydrogel, each component is reconstituted with sterile saline solution (pH 6.8-7.2) and then mixed together.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1