Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
• Generic Name: Full field digital, system, x-ray, mammographic
• Regulation Number: 892.1715
• Applicant: GE Healthcare; 3000 N. GRANDVIEW BLVD; WAUKESHA, WI 53188
• PMA Number: P990066
• Date Received: 10/29/1999
• Decision Date: 01/28/2000
• Reclassified Date: 12/06/2010
• Product Code: MUE
• Docket Number: 00M-0579
• Notice Date: 02/16/2000
• Advisory Committee: Radiology
• Expedited Review Granted?: No
• Combination Product: No
• Recalls: CDRH Recalls
• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Supplements: S016 S003 S004 S002 S013 S014 S015 S026 S027 S035 S031 ; S032 S033 S036 S037 S011 S012 S025 S024 S029 S001 S019 S020 ; S021 S022 S023 S005 S006 S007 S008 S009 S010 S017 S030 S034 ; S028