PMA P970018S003

Device: PREPSTAIN SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S003
Product code: MKQ
Decision date: 2001-11-02
Classification: Processor, Cervical Cytology Slide, Automated
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL FOR NAME CHANGES FROM AUTOCYTE PREP SYSTEM TO PREPSTAIN SYSTEM AND FROM CYTORICH TO SUREPATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PREPSTAIN SYSTEM AND SUREPATH. THE PREPSTAIN SYSTEM AND SUREPATH IS INDICATED AS A LIQUID-BASED, THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. THE PREPSTAIN SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRECANCEROUS 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: S003
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2001-11-02
Decision code: APPR
Date received: 2001-10-26
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR NAME CHANGES FROM AUTOCYTE PREP SYSTEM TO PREPSTAIN SYSTEM AND FROM CYTORICH TO SUREPATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES PREPSTAIN SYSTEM AND SUREPATH. THE PREPSTAIN SYSTEM AND SUREPATH IS INDICATED AS A LIQUID-BASED, THIN LAYER CELL PREPARATION PROCESS. THE PREPSTAIN SYSTEM PRODUCES SLIDES THAT ARE INTENDED AS REPLACEMENTS FOR CONVENTIONAL GYNECOLOGIC PAP SMEARS. THE PREPSTAIN SLIDES ARE INTENDED FOR USE IN THE SCREENING AND DETECTION OF CERVICAL CANCER, PRECANCEROUS LESIONS, ATYPICAL CELLS AND ALL OTHER CYTOLOGIC CATEGORIES AS DEFINED BY THE BETHESDA SYSTEM FOR REPORTING CERVICAL/VAGINAL CYTOLOGIC DIAGNOSES.