|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||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change to use an additional shipping container for the apligraf(tm) device that would maintain product integrity for a period of 72 hours. The change will allow for greater flexibility with domestic shipments by ensuring product integrity for a longer period, and reduuce waste.