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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
ApplicantTRIPATH IMAGING, INC.
PMA NumberP950009
Supplement NumberS013
Date Received09/15/2011
Decision Date11/10/2011
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 software changes to the bd focalpoint slide profiler from the current production version apps 3. 4. 1a to apps 3. 5. 0.
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