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In this section: Pediatric Advisory Committee

Epicel (cultured epidermal autograft)(HDE) Briefing Materials

For the March 7, 2017 meeting of the FDA's Pediatric Advisory Committee

Persons with disabilities having problems accessing any of the PDF files below may call 240-402-3838 for assistance.

Briefing Materials

Epicel 2017 Executive Summary
Epicel Summary of Safety and Probable Benefit
Epicel Clinical Review Memo BH0990200/21
Epicel Clinical Review Memo BH0990200/34
Epicel- Dear Health Care Provider Letter (2014)
Epicel- Patient Information Label (2014)
Epicel- HDE Supplement Approval Order (2016)
Epicel- Directions for Use (2016)

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