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Artefill PMMA/Collagen Implant Gains Panel Nod With Conditions

This article was originally published in The Gray Sheet

Executive Summary

Artes Medical should develop patient and physician educational materials for its Artefill PMMA/collagen dermal implant in addition to standard labeling, FDA's General & Plastic Surgery Devices Panel recommends

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Collagen Implant PMA “Approvable” Letter Facilitates 2004 Launch – Artes

Artes Medical maintains that within six months FDA will inspect a collagen manufacturing facility under development, permitting U.S. launch of facial wrinkle treatment Artefill later this year

Collagen Implant PMA “Approvable” Letter Facilitates 2004 Launch – Artes

Artes Medical maintains that within six months FDA will inspect a collagen manufacturing facility under development, permitting U.S. launch of facial wrinkle treatment Artefill later this year

Inamed wrinkle treatments

Firm receives supplemental PMA approval for CosmoDerm and CosmoPlast human collagen devices March 12. CosmoDerm is indicated for use in "the superficial papillary dermis for correction of soft tissue contour deficiencies such as wrinkles and acne scars," while CosmoPlast "is injected into the mid to deep dermis for the same results." The approvals are based on an earlier PMA for Zyderm and Zyplast bovine collagen products. The devices, which use Advanced Tissue Sciences' human collagen, require no skin-allergy testing prior to injection. Artes Medical's PMMA/collagen implant may not be far behind following an FDA panel nod last month (1"The Gray Sheet" March 3, 2003, p. 26)...

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