|Trade Name||SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM|
|Classification Name||full field digital,system,x-ray,mammographic|
|Generic Name||full field digital,system,x-ray,mammographic|
|Supplement Type||30-day notice|
|Supplement Reason|| process change - manufacturer/sterilizer/packager/supplier|
|Expedited Review Granted?|| No|
|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.