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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePATHVYSION HER-2 DNA PROBE KIT
Classification Namesystem, test, her-2/neu, nucleic acid or serum
Generic Namesystem, test, her-2/neu, nucleic acid or serum
Applicant
ABBOTT MOLECULAR, INC.
1300 east touhy avenue
des plaines, IL 60018
PMA NumberP980024
Supplement NumberS004
Date Received12/22/2010
Decision Date01/10/2011
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
PROCESS CHANGE TO THE MANUFACTURE OF THE FISH DNA BULK PROBE SOLUTION TO INCREASE THE BATCH RANGE UP TO 2000 ML.
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