Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Product Classification
  • Print
  • Share
  • E-mail
-
New Search Back to Search Results
Device cultured human cell skin dressing
Definition Allogeneic skin cells cultured in vitro and combined with scaffold sheeting to act as a physical wound covering and provide biological components that interact with the wound, for treatment of skin ulcers.
Physical State Allogeneic skin cells are cultured in vitro and combined with scaffold sheeting
Technical Method Device funtions as a physical wound covering and provides biological components that interact with the wound
Target Area Skin
Review Panel General & Plastic Surgery
Product CodePFC
Premarket Review Center for Biologics Evaluation & Research (CBER)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
-
-