PMA P990066S032

Device: GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S032
Product code: MUE
Decision date: 2008-07-30
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL OF MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER (APPROVED UNDER P990066/S022).

Current openFDA PMA Record#

Device: GE HEALTHCARE SENOGRAPHE 2000D DIGITAL MAMMOGRAPHY SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S032
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2008-07-30
Decision code: APPR
Date received: 2008-06-30
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL OF MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER (APPROVED UNDER P990066/S022).