PMA P970018S006

Device: PREPSTAIN (TM) SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S006
Product code: MKQ
Decision date: 2003-05-02
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL TO MODIFY THE CURRENT APPROVED LABELING TO INCLUDE DATA AND INFORMATION FROM A DIRECT-TO-VIAL CLINICAL STUDY FOR HIGH GRADE SQUAMOUS INTRAEPITHELIAL AND MORE SEVERE LESIONS.

Current openFDA PMA Record#

Device: PREPSTAIN (TM) SYSTEM
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S006
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2003-05-02
Decision code: APPR
Date received: 2003-03-24
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO MODIFY THE CURRENT APPROVED LABELING TO INCLUDE DATA AND INFORMATION FROM A DIRECT-TO-VIAL CLINICAL STUDY FOR HIGH GRADE SQUAMOUS INTRAEPITHELIAL AND MORE SEVERE LESIONS.