|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Classification Name||dressing, wound and burn, interactive|
||General & Plastic Surgery
|Supplement Type|| Special Supplement|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the introduction of additional in-process bioburden testing and quality assurance steps to enhance the safety profile of apligraf.