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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 Namecervical cytology device
PMA NumberP950009
Supplement NumberS017
Date Received12/02/2013
Decision Date02/26/2014
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for replacement of the current scan controller board (scb) utilized in the bd focalpoint¿ slide profiler with digital image system configuration.