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 thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy

• Apligra (Graftskin) – P950032

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Biologics License Application (BLA)

 GINTUIT

BLA/ STN#: 125400/0

March 9, 2012

Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) Cellular Sheet for Topical Oral Application

Indications and Usage

GINTUIT (Allogeneic Cultured Keratinocytes and Fibroblasts in Bovine Collagen) 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.

GINTUIT is not intended to provide root coverage.

Dosage

For single patient use only. GINTUIT is used as one application over a surgically created vascular wound bed in the oral cavity. The size of GINTUIT is adjusted for the size of the wound bed. The safety and efficacy of repeat application(s) of GINTUIT have not been established.

• Summary Basis for Regulatory Action for Gintuit

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Last Updated: 2015-12-09