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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.
 
DeviceUROVYSION BLADDER CANCER KIT ASSAY
Generic NameTest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
ApplicantABBOTT MOLECULAR
1300 E. Touhy Avenue
Des Plaines, IL 60018
PMA NumberP030052
Supplement NumberS009
Date Received07/13/2012
Decision Date08/10/2012
Product Code NSD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ELIMINATE A SECOND CLONE IDENTITY TESTING PROCEDURE AT THE FERMENTATION STAGE FOR LSI 9P21, QUALIFY THE GENEPREP INSTRUMENT, QUALIFY THE OVERHEADMIXING SYSTEM AND VALIDATION OF MIXING PROCESS IN THE MANUFACTURE OF HYBRIDIZATION BUFFER,IMPLEMENT THE OPTICAL DENSITY READING AS AN ADDITIONAL IN PROCESS QUALITY CONTROL, VALIDATE ANEXISTING MIXING PROCESS FOR THE UROVYSION BULK SOLUTION, AND TRANSFER AN EXISTING IN-PROCESS TESTING OF LABELED DNA.
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