PMA P990066S026

Device: SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
Applicant: GE Healthcare
PMA number: P990066
Supplement: S026
Product code: MUE
Decision date: 2007-01-03
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER THAT FDA APPROVED UNDER P990066/S022.

Current openFDA PMA Record#

Device: SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
Applicant: GE Healthcare
PMA number: P990066
Supplement: S026
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2007-01-03
Decision code: APPR
Date received: 2006-12-01
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER THAT FDA APPROVED UNDER P990066/S022.