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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 Ave.
Des Plaines, IL 60018
PMA NumberP030052
Supplement NumberS015
Date Received06/16/2014
Decision Date07/16/2014
Product Code NSD 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
MODIFY THE VALIDATED TEST METHOD MDP00644 FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
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