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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 NameTHE PATH VYSION HER-2 DNA PRODE KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP980024
Supplement NumberS011
Date Received11/05/2013
Decision Date11/27/2013
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changing the configuration of their current label printer, label printing software, and label inspection system for the following fish assays: vysis alk break apart fish probe kit, urovysion bladder cancer kit, and pathvysion her-2dna probe kit.
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