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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.
 
DevicePATH VYSION 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 NumberS013
Date Received06/16/2014
Decision Date07/16/2014
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 
MODIFY THE VALIDATED TEST METHOD MDP00644 ¿FRAGMENTED DNA AGAROSE GEL ELECTROPHORESIS¿ OF THE MANUFACTURING PROCESS OF VYSIS ALK BREAK APART FISH PROBE KIT, PATHVYSION HER-2 DNA PROBE KIT AND UROVYSION BLADDER CANCER KIT.
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