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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 TOTALYS SLIDEPREP
Generic NameProcessor, cervical cytology slide, automated
ApplicantBd Diagnostic Systems
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP970018
Supplement NumberS030
Date Received11/03/2014
Decision Date02/12/2016
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the BD Totalys™ SlidePrep (and use of the BD FocalPoint™ Slide Profiler with slides prepared by the BD Totalys™ SlidePrep). The devices, as modified, will be marketed under the trade names BD Totalys™ SlidePrep and BD FocalPoint™ Slide Profiler, respectively.
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