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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.
 
DeviceURO VYSION BLADDER CANCER KIT
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 NumberS013
Date Received11/05/2013
Decision Date11/27/2013
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  
CHANGING THE CONFIGURATION OF THEIR CURRENT LABEL PRINTER, LABEL PRINTING SOFTWARE,AND LABEL INSPECTION SYSTEM FOR THE FOLLOWING FISH ASSAYS: VYSIS ALK BREAK APART FISH PROBE KIT, UROVYSION BLADDER CANCER KIT, AND PATHVYSION HER-2DNA PROBE KIT.
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