PMA P950009S023
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S023
- Product code
- MNM
- Decision date
- 2019-12-06
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Like-for-like replacement of Lamp House components.
Current openFDA PMA Record#
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S023
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2019-12-06
- Decision code
- OK30
- Date received
- 2019-11-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Like-for-like replacement of Lamp House components.