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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 NumberS009
Date Received01/10/2005
Decision Date02/11/2005
Product Code MKQ 
Advisory Committee Pathology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION TO THE SUREPATH SLIDE PREPARATION METHOD WHICH WILL BE MARKETED UNDER THE TRADE NAME PREPSTAIN SYSTEM AND IS INDICATED FOR USE AS A LIQUID-BASED THIN LAYER CELL PREPARATION PROCESS. THE PRESTAIN SYSTEM PRODUCES SUREPATH SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. SUREPATH SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRE-CANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.
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