PMA P990066S025
- Device
- SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S025
- Product code
- MUE
- Decision date
- 2006-10-20
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- ADDITION OF GE HEALTHCARE/FINLAND AS AN ALTERNATE SUPPLIER FOR THE X-RAY BUCKYS USED ON THE DEVICE.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S025
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2006-10-20
- Decision code
- OK30
- Date received
- 2006-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF GE HEALTHCARE/FINLAND AS AN ALTERNATE SUPPLIER FOR THE X-RAY BUCKYS USED ON THE DEVICE.