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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 NamePATHVYSION HER-2 DNA PROBE KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP980024
Supplement NumberS005
Date Received02/22/2011
Decision Date04/18/2011
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Immunology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the implementation of process changes to the manufacture of the pathvysion her-2 dna probe kit assay, including a new fish dna extraction process, and rna reduction step, new sonication equipment, and a new amination/labeling procedure.
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