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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 Ave.
Des Plaines, IL 60018
PMA NumberP030052
Supplement NumberS004
Date Received02/25/2011
Decision Date03/22/2011
Product Code NSD 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO PROVIDE THE DEFINITION FOR THE PEPSIN ACTIVITY OF THE VYSIS PROTEASE REAGENT IN THE UROVYSION PACKAGE INSERT.
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