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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
ApplicantVYSIS
PMA NumberP030052
Supplement NumberS001
Date Received06/20/2005
Decision Date05/10/2006
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Typenormal 180 day track no user fee
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at abbott des plaines, des plaines, illinois.
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