PMA P990066S006
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S006
- Product code
- MUE
- Decision date
- 2001-10-01
- 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 COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING). THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S006
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2001-10-01
- Decision code
- OK30
- Date received
- 2001-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SUPPLIER FOR THE COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING). THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.