|Classification Name||agent, bulking, injectable for gastro-urology use|
|Generic Name||agent, bulking, injectable for gastro-urology use|
|Applicant||VALEANT PHARMACEUTICALS NORTH AMERICA, LLC|
|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 for performing the protein testing in-house at the q-med quality control laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as modified, will be marketed under the trade name deflux and is indicated for the treatment of vesicoureteral reflux in children.