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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameUROVYSION BLADDER CANCER KIT
Classification Nametest, fluorescence in situ hybridization (fish), for bladder cancer detection and monitoring for recurrence
Generic Namefluorescence in situ hybridization(fish) reagents
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP030052
Supplement NumberS006
Date Received04/28/2011
Decision Date05/26/2011
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to the urovysion bladder cancer kit package insert to correct an inaccuracy in a labeling schematic in the urovysion package insert 30-608358 identified during a review of the package insert.
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