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Vaccines, Blood & Biologics

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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
  • 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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