Humanitarian Device Exemption (HDE)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.

• Trade Name: Epicel
• Classification Name: cultured epithelial autograft
• Generic Name: oce
• Applicant: Vericel Corporation; 64 sidney street; cambridge, MA 02139
• HDE Number: BH990200
• Supplement Number: 38
• Date Received: 02/08/2016
• Decision Date: 03/08/2016
• Product Code: OCE [ Registered Establishments with OCE ]
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: Yes