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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
Generic NameProcessor, cervical cytology slide, automated
ApplicantBd Diagnostic Systems
4025 Stirrup Creek Dr., Suite 400
Durham, NC 27703
PMA NumberP970018
Supplement NumberS029
Date Received11/15/2013
Decision Date12/13/2013
Product Code MKQ 
Advisory Committee Pathology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVAL OF AN IN-PROCESS QUALITY CONTROL (QC) TEST AND A FINAL RELEASE TEST ASSOCIATED WITH THE MANUFACTURE OF BD DENSITY REAGENT.
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