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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 NumberS011
Date Received01/16/2013
Decision Date02/10/2013
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an alternate supplier for human placental (hp) dna which is a component of the pathvysion her-2 dna probe kit and the urovysion bladder cancer kit.
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