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Vaccines, Blood & Biologics
ARTISS
Proper Name: Fibrin Sealant (Human)
Tradename: ARTISS
Manufacturer: Baxter Healthcare Corp, License #0140
Package Insert (PDF - 216 KB) - Approved: March 19, 2008
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
Contact Us
Consumer Affairs Branch (CBER)
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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