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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEFLUX
Generic NameAGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE
ApplicantPalette Life Sciences
27 East Cota Street
Suite 402
Santa Barbara, CA 93101
PMA NumberP000029
Supplement NumberS013
Date Received06/06/2005
Decision Date12/12/2005
Product Code LNM 
Advisory Committee Gastroenterology/Urology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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.
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