PMA P990066S031
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S031
- Product code
- MUE
- Decision date
- 2008-07-16
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- CHANGE TO SPLIT THE MANUFACTURING PROCESS INTO TWO SEPARATE PARALLEL LINES.
Current openFDA PMA Record#
- Device
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S031
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2008-07-16
- Decision code
- OK30
- Date received
- 2008-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO SPLIT THE MANUFACTURING PROCESS INTO TWO SEPARATE PARALLEL LINES.