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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 NumberS006
Date Received10/17/2011
Decision Date02/27/2012
Product Code
MVD
Advisory Committee Pathology
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 manufacturing process changes to the pathvysion her-2 dna probe kit, including changes associated with fish probe restriction enzyme digested gel electrophoresis (dna restriction analysis), implementation of an in-process validated test method for a260 absorbance readings, addition of an incoming screening test for dextran sulfate and revision to manufacturing procedure document for lsi her-2/neu aminated dna.
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