Product Approval Information
Proper Name: Fibrin Sealant (Human)
Tradename: ARTISS
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert (PDF - 216 KB) - Approved: March 19, 2008
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Date: March 19, 2008
Indication: To adhere autologous skin grafts to surgically prepared wound beds resulting from burns in adult and pediatric populations
Approval Letter
FDA Approves New Medical Adhesive to Treat Burn Patients - March 19, 2008
Summary Basis for Regulatory Action
Approval History, Letters, Reviews, and Related Documents