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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.
 
DeviceBD FOCALPOINT SYSTEM
Generic NameREADER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
ApplicantBd Diagnostics
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP950009
Supplement NumberS009
Date Received03/26/2009
Decision Date07/24/2009
Product Code MNM 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN CHANGES TO THE IMAGE, CAPTURE AND FOCUS (ICF) CIRCUIT BOARD IN THE BD FOCALPOINT PROFILER.
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