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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 NamePATH VYSION HER-2 DNA PROBE KIT ASSAY
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Nameneu gene assay kit
ApplicantABBOTT MOLECULAR, INC.
PMA NumberP980024
Supplement NumberS007
Date Received06/14/2012
Decision Date12/20/2012
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 manufacturing change to components of the probechek her-2/neu cutoff control slides used in the pathvysion her-2 dna probe kit. The change included creation of a new master cell bank and a new working cell bank from seed stock of hs578t cells, used in the manufacture of the probechek her-2/neu cutoff control slides.
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