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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.
 
DeviceAUTOCYTE PREP SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantBd Diagnostic Systems
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP970018
Supplement NumberS001
Date Received08/08/2000
Decision Date08/29/2000
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE PROTOCOL FOR THE AUTOCYTE PREP POST-APPROVAL STUDY.
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