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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DevicePREPSTAIN SYSTEM
Classification Nameprocessor, cervical cytology slide, automated
Generic Nameprocessor, cervical cytology slide, automated
Applicant
BD Diagnostic Systems
4025 stirrup creek drive
suite 400
durham, NC 27703
PMA NumberP970018
Supplement NumberS016
Date Received06/09/2009
Decision Date07/02/2009
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes to the method of manufacturing from a manual process to an automated process to reduce production costs and improve control of the manufacturing process.
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