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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/PREPMATE
Generic NameProcessor, cervical cytology slide, automated
ApplicantBD Diagnostic Systems
4025 STIRRUP CREEK DRIVE
SUITE 400
DURHAM, NC 27703
PMA NumberP970018
Supplement NumberS024
Date Received08/24/2011
Decision Date09/21/2011
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL. REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING.
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