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510(k) Data Aggregation
K Number
K134037Device Name
PREMVIA
Manufacturer
Date Cleared
2014-08-07
(219 days)
Product Code
Regulation Number
N/AWhy 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.
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