PMA P970018S009

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S009
Product code: MKQ
Decision date: 2005-02-11
Generic name: Processor, cervical cytology slide, automated
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.

Current openFDA PMA Record#

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S009
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2005-02-11
Decision code: APPR
Date received: 2005-01-10
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
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.