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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 PrepStain System, BD Totalys MultiProcessor, BD Totalys SlidePre, BD SurePath Liquid-based Pap Test
Generic NameProcessor, cervical cytology slide, automated
ApplicantBd Diagnostic Systems
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP970018
Supplement NumberS041
Date Received08/13/2024
Decision Date09/06/2024
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Requested approval for specific labeling change that removes language indicating that user training for the PrepStain System must be provided by BD but maintains that laboratory personnel must be qualified to prepare or evaluate cytology slides prepared using the respective instrumentation.
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