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GINTUIT, Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
药品名称
GINTUIT, Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
承诺描述
Assess the safety and effectiveness of Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival disorders in pediatric patients ages 12 to 18 years.
承诺状态描述
Deferral Extension Requested 08/17/2017, and received 08/21/2017. Denied per FDA letter dated October 5, 2017.