PMA P950009S021

Device: BD FOCALPOINT GS IMAGING SYSTEM
Applicant: Bd Diagnostics
PMA number: P950009
Supplement: S021
Product code: MNM
Decision date: 2016-06-17
Classification: Reader, Cervical Cytology Slide, Automated
Generic name: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement: Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.

Current openFDA PMA Record#

Device: BD FOCALPOINT GS IMAGING SYSTEM
Applicant: Bd Diagnostics
PMA number: P950009
Supplement: S021
Product code: MNM
Generic name: READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date: 2016-06-17
Decision code: OK30
Date received: 2016-05-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to the printed circuit board reported in this supplement in conjunction with the changes to replace VIC chip and change of manufacturing supplier qualify.