|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|| labeling change - shelf-life|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for a change in product expiration dating from 5 days at 20-37degrees c to 15 days at 20-23 degrees c.