PMA P990066S022

Device: SENOGRAPHE DS & 2000D FFDM SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S022
Product code: MUE
Decision date: 2005-10-17
Classification: Full Field Digital, System, X-ray, Mammographic
Generic name: Full field digital, system, x-ray, mammographic
Approval order statement: APPROVAL TO ADD LABELING ALERTING USER THAT IMAGES MAY BE DISPLAYED IN A MANNER DIFFERENT FROM THAT SPECIFIED IN MQSA REQUIREMENTS.

Current openFDA PMA Record#

Device: SENOGRAPHE DS & 2000D FFDM SYSTEM
Applicant: GE Healthcare
PMA number: P990066
Supplement: S022
Product code: MUE
Generic name: Full field digital, system, x-ray, mammographic
Decision date: 2005-10-17
Decision code: APPR
Date received: 2005-09-13
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO ADD LABELING ALERTING USER THAT IMAGES MAY BE DISPLAYED IN A MANNER DIFFERENT FROM THAT SPECIFIED IN MQSA REQUIREMENTS.