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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 NumberS014
Date Received06/01/2016
Decision Date07/13/2016
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 
Removal of testing at the cell pellet stage for 2 components of the PathVysion HER-2 DNA Probe Kit: (1) ProbeChek HER-2/neu Cut-Off Control Slides (List No. 02J04-030), (2) ProbeChek HER-2/neu Normal Control Slides (List No. 02J05-030). The second change involves adding the RM2255 Rotary Microtome to the manufacturing procedures of the ProbeChek HER-2/neu Cut-Off Control Slides, the ProbeChek Her-2/neu Normal Control Slides, and 2 components of the Vysis ALK Break Apart FISH Probe Kit: (1) ProbeChek ALK Negative Control Slides (06N38-005), (2) ProbeChek ALK Postitive Control Slides (06N38-010).
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