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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.
 
Trade NameBD FOCALPOINT SLIDE PROFILER
Classification Namereader, cervical cytology slide, automated
Generic Namecervical cytology device
ApplicantBD DIAGNOSTICS
PMA NumberP950009
Supplement NumberS016
Date Received07/05/2012
Decision Date08/30/2012
Product Code
MNM[ Registered Establishments with MNM ]
Advisory Committee Pathology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for change of the scan controller board for the device.
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