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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.
 
DevicePREPSTAIN SYSTEM
Generic NameProcessor, cervical cytology slide, automated
ApplicantBD Diagnostic Systems
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP970018
Supplement NumberS004
Date Received07/02/2002
Decision Date10/01/2002
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeNormal 180 Day Track
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR STOPPING THE POST-APPROVAL REPORTING REQUIREMENT FOR A DIRECT-TO-VIAL STUDY FOR THE PREPSTAIN SYSTEM.
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