|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||agent, bulking, injectable for gastro-urology use|
|Applicant||SALIX PHARMACEUTICALS, INC.|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Addition of the possibility to store samples for bioburden analysis in a refrigerator at a temperature of 5 degree celsius for up to 18 hours before analysis.