|Classification Name||dressing, wound and burn, interactive|
|Generic Name||dressing, wound and burn, interactive|
||General & Plastic Surgery
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the relative humidity of the lunaire incubators used in the apligraf manufacturing process. The change will decrease the risk of bacterial contamination due to waterborne organisms during the manufacturing process.