HDE: BH990200.34
Tradename: Epicel (cultured epidermal autografts)
Manufacturer: Vericel Corporation
Indications:

• Indicated for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.

Approval Date: February 18, 2016
 

Product Information

• Directions for Use - Epicel (cultured epidermal autografts)
• Patient Information - Epicel (cultured epidermal autografts)

Supporting Documents

• Approval Order - Epicel (cultured epidermal autografts)
• June 2014 Dear Health Care Provider Letter - Epicel (cultured epidermal autografts)