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. |
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Device | PREPSTAIN SYSTEM |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | BD Diagnostic Systems 4025 STIRRUP CREEK DRIVE SUITE 400 DURHAM, NC 27703 |
PMA Number | P970018 |
Supplement Number | S009 |
Date Received | 01/10/2005 |
Decision Date | 02/11/2005 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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