Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: ORCEL BILAYERED CELLULAR MATRIX
• Generic Name: Dressing, wound and burn, interactive
• Applicant: FORTICELL BIOSCIENCE; 3960 BROADWAY; NEW YORK, NY 10032
• PMA Number: P010016
• Date Received: 03/05/2001
• Decision Date: 08/31/2001
• Conversion Date: 08/14/2013
• Product Code: MGR
• Docket Number: 01M-0413
• Notice Date: 09/20/2001
• Advisory Committee: General & Plastic Surgery
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
APPROVAL FOR THE ORCE BILAYERED CELLULAR MATRIX. THE DEVICE IS INDICATED FOR THE TREATMENT OF FRESH, CLEAN SPLIT THICKNESS DONOR SITE WOUNDS IN BURN PATIENTS.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S001 S002