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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,PROBECHEK CONTROL SLIDES FOR UROVYSION BLADDER CANCER KIT
Generic NameTest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
ApplicantAbbott Molecular
1300 E Touhy Ave.
Des Plaines, IL 60018
PMA NumberP030052
Supplement NumberS017
Date Received11/12/2015
Decision Date12/29/2015
Product Code NSD 
Advisory Committee Pathology
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MANUFACTURING PROCESS CHANGES TO COMPONENTS OF THEPROBECHEK CONTROL SLIDES FOR FISH USING UROVYSION BLADDER CANCER KIT.
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