Class III Medical Device and Biologics License Application (BLA) Class III Medical Device APLIGRAF: P950032 Expedited processing eras authorized on May 30 1995 based on the potential of Apligraf to provide a clinically important advance over existing alternatives in the treatment of chronic venous insufficiency ulcers. Intended Use/Indications Apligraf is indicated for use with standard therapeutic compression for the treatment of non infected partial and full
Wound and Burn Dressing Summary of Regulatory Approval Pathways Class III Device PMA Combination Product Product Code: MGR PMA Devices 1). Integra Dermal Regeneration Template: P900033 (a device to treat the skin of people with severe burns) INTEGRA® Dermal Regeneration Template is a device to treat the skin of people with severe burns. FDA has recently expanded the approved use of this
By Regulatory Doctor; LinkedIn; Google Plus; Twitter; Facebook Fish-Skin Tissue Regeneration Technology to Heal Human Wounds On October 23, 2013, the US FDA cleared a 510(k) [K132343] to market a proprietary fish-skin technology, marketed as MariGen Omega3, for the treatment of chronic wounds in the US. The MariGen Omega3 is manufactured by Kerecis in Iceland from fish locally harvested in the North Atlantic waters.