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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.
Classification Namereader, cervical cytology slide, automated
Generic Namereader, cervical cytology slide, automated
4025 stirrup creek drive
suite 400
durham, NC 27703
PMA NumberP950009
Supplement NumberS009
Date Received03/26/2009
Decision Date07/24/2009
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design changes to the image, capture and focus (icf) circuit board in the bd focalpoint profiler.