PMA P970018S024

Device: PREPSTAIN SYSTEM/PREPMATE
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S024
Product code: MKQ
Decision date: 2011-09-21
Classification: Processor, Cervical Cytology Slide, Automated
Generic name: Processor, cervical cytology slide, automated
Approval order statement: APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL. REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING.

Current openFDA PMA Record#

Device: PREPSTAIN SYSTEM/PREPMATE
Applicant: Bd Diagnostic Systems
PMA number: P970018
Supplement: S024
Product code: MKQ
Generic name: Processor, cervical cytology slide, automated
Decision date: 2011-09-21
Decision code: APPR
Date received: 2011-08-24
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR UPDATING THE PRODUCT LABELING AND THE PREPMATE OPERATOR MANUAL. REQUESTED CHANGES TO THE PRODUCT LABELING INCLUDE UPDATING THE MET MARK, UPDATING THE MANUFACTURING ADDRESS AND EC AUTHORIZED REPRESENTATIVE NAME AND ADDRESS, ADDING CE MARK, AND ADDING BD BRANDING TO SERIAL NUMBER LABELS AND BOX LABELS. CHANGES TO THE OPERATOR MANUAL INCLUDE EDITORIAL CHANGES INTENDED TO CLARIFY AND/OR CORRECT SOME EXISTING TEXT, WHICH INCLUDED UPDATING THE COMPANY AND INSTRUMENT NAME AND BRANDING.