PMA P990066S012
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S012
- Product code
- MUE
- Decision date
- 2002-04-03
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- ADDITION OF A SUPPLIER OF THE HIGH VOLTAGE (HV) TANK ELECTRONIC BOARDS. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S012
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2002-04-03
- Decision code
- OK30
- Date received
- 2002-03-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SUPPLIER OF THE HIGH VOLTAGE (HV) TANK ELECTRONIC BOARDS. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.