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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 ASSAY
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 NumberS007
Date Received05/06/2011
Decision Date06/01/2011
Product Code
NSD[ Registered Establishments with NSD ]
Advisory Committee Immunology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of process change to the manufacture of the fish dna bulk probe solution, including a new fish dna extraction process, a new sonication equipment, a new amination/labeling procedure, and a supplemental dna purification processing step to reduce rna carry-over.
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