PMA P990066S011
- Device
- GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S011
- Product code
- MUE
- Decision date
- 2002-02-22
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- ADDITION OF A SUPPLIER FOR THE GANTRY ELECTRONIC BOARDS OF THE SENOGRAPHE 2000D FFDM SYSTEM. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
Current openFDA PMA Record#
- Device
- GEMS SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S011
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2002-02-22
- Decision code
- OK30
- Date received
- 2002-02-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SUPPLIER FOR THE GANTRY ELECTRONIC BOARDS OF THE SENOGRAPHE 2000D FFDM SYSTEM. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.