PMA P950009

Device
BD FocalPoint GS Imaging System
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S026
Product code
MNM
Decision date
2022-07-11
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Approval order statement
Change of supplier for an instrument component.

Current openFDA PMA Record#

Device
BD FocalPoint GS Imaging System
Applicant
Bd Diagnostics
PMA number
P950009
Supplement
S026
Product code
MNM
Generic name
READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
Decision date
2022-07-11
Decision code
OK30
Date received
2022-06-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Change of supplier for an instrument component.