|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||real-time process|
|Supplement Reason|| change design/components/specifications - other|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a new cell strain, hep 040, for introduction into production of apligraf. The device, as modified, will be marketed under the trade name apligraf and is indicated for the treatment of partial and full thickness chronic venous ulcers.