PMA P950009S024
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S024
- Product code
- MNM
- Decision date
- 2021-03-29
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Approval order statement
- Component replacement with the like-for-like objective lens.
Current openFDA PMA Record#
- Device
- BD FocalPoint GS Imaging System
- Applicant
- Bd Diagnostics
- PMA number
- P950009
- Supplement
- S024
- Product code
- MNM
- Generic name
- READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED
- Decision date
- 2021-03-29
- Decision code
- OK30
- Date received
- 2021-03-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Component replacement with the like-for-like objective lens.