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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 NumberS005
Date Received02/22/2011
Decision Date04/18/2011
Product Code
MVD[ Registered Establishments with MVD ]
Advisory Committee Pathology
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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