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
[youtube_advanced url=”https://www.youtube.com/watch?v=c87iBUvxkbM” controls=”no” rel=”no” modestbranding=”yes”]
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.
[download id=”22316″]
[youtube_advanced url=”https://www.youtube.com/watch?v=PTBlVBZ2DyA” controls=”no” rel=”no” modestbranding=”yes”]
[button url=”http://globalcomplianceseminar.com” target=”blank” style=”3d” background=”#c91119″ size=”10″ wide=”yes” center=”yes”]Learn here about FDA training seminars[/button]
Last Updated: 2015-12-09
Comments are closed.