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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
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 NumberS002
Date Received01/08/2007
Decision Date02/06/2007
Product Code NSD 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF THE THERMOBRITE AUTOMATED SLIDE HEATING PLATE SUPPLIED BY AN ALTERNATE VENDOR AS AN OPTIONAL ALTERNATIVE OF THE HYBRITE AUTOMATED SLIDE HEATING PLATE INSTRUMENT AND TO ADD INSTRUCTIONS FOR USE OF SAID THERMOBRITE TO THE CURRENT UROVYSION BLADDER CANCER KIT PACKAGE INSERT.
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