|Classification Name||dressing, wound and burn, interactive|
|Generic Name||dressing, wound and burn, interactive|
||General & Plastic Surgery
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to use a rapid microbial method, as an alternate sterility testing method for all in-process liquid samples currently tested per united states pharmacopeia <71>, sterility tests.