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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.
 
Trade NameBD PREPSTAIN SYSTEM VACUUM PUMP SAFETY HAZARD
Classification Nameprocessor, cervical cytology slide, automated
Generic Namecervical cytology slide preparation device
ApplicantTRIPATH IMAGING, INC.
PMA NumberP970018
Supplement NumberS023
Date Received06/27/2011
Decision Date07/15/2011
Product Code
MKQ[ Registered Establishments with MKQ ]
Advisory Committee Pathology
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for vacuum pump safety hazard labeling changes.
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