Vaccines, Blood & Biologics
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GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen)
STN: BL 125400/0
Proper Name: Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen
Trade Name: GINTUIT
Manufacture: Organogenesis Incorporated
Indication: Is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.
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Supporting Documents
March 9, 2012 Approval Letter - GINTUIT
Is an allogeneic cellularized scaffold product indicated for topical (non-submerged) application to a surgically created vascular wound bed in the treatment of mucogingival conditions in adults.Summary Basis for Regulatory Action, March 9, 2012 - Gintuit (PDF - 205KB)Approval History, Letters, Reviews, and Related Documents - GINTUIT
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Related Information
FDA approves first cell-based product to treat oral mucogingival conditions in adults
Press Release: March 9, 2012GINTUIT - Questions and Answers FDA Online Label Repository
Search this database for drug labeling and other information. The content has not been altered or verified by the FDA and may not be the labeling on currently distributed products or identical to the labeling that is approved.
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