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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 NumberS007
Date Received05/06/2011
Decision Date06/01/2011
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  
IMPLEMENTATION OF PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION, INCLUDING A NEW FISH DNA EXTRACTION PROCESS, A NEW SONICATION EQUIPMENT, A NEW AMINATION/LABELING PROCEDURE, AND A SUPPLEMENTAL DNA PURIFICATION PROCESSING STEP TO REDUCE RNA CARRY-OVER.
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