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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameORCEL BILAYERED CELLULAR MATRIX
Classification Namedressing, wound and burn, interactive
Generic Nameinteractive wound and burn dressing
ApplicantFORTICELL BIOSCIENCE
PMA NumberP010016
Date Received03/05/2001
Decision Date08/31/2001
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 01M-0413
Notice Date 09/20/2001
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 
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