SENOGRAPHE DS & 2000D FFDM SYSTEM

Full Field Digital, System, X-ray, Mammographic

FDA Premarket Approval P990066 S022

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval to add labeling alerting user that images may be displayed in a manner different from that specified in mqsa requirements.

DeviceSENOGRAPHE DS & 2000D FFDM SYSTEM
Classification NameFull Field Digital, System, X-ray, Mammographic
Generic NameFull Field Digital, System, X-ray, Mammographic
ApplicantGE Healthcare
Date Received2005-09-13
Decision Date2005-10-17
PMAP990066
SupplementS022
Product CodeMUE
Advisory CommitteeRadiology
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188

Supplemental Filings

Supplement NumberDateSupplement Type
P990066Original Filing
S037 2010-06-22 135 Review Track For 30-day Notice
S036 2010-04-27 30-day Notice
S035 2010-01-14 Normal 180 Day Track
S034 2009-10-13 Real-time Process
S033 2009-05-21 Real-time Process
S032 2008-06-30 Special (immediate Track)
S031 2008-06-23 30-day Notice
S030 2008-03-26 Real-time Process
S029 2007-05-21 Real-time Process
S028 2007-02-21 Real-time Process
S027 2006-12-11 Real-time Process
S026 2006-12-01 Special (immediate Track)
S025 2006-09-27 30-day Notice
S024 2006-08-02 Special (immediate Track)
S023 2006-04-17 Special (immediate Track)
S022 2005-09-13 Special (immediate Track)
S021 2005-06-01 Normal 180 Day Track
S020 2005-05-03 Normal 180 Day Track
S019 2005-04-18 Real-time Process
S018
S017 2004-04-12 Normal 180 Day Track No User Fee
S016 2003-09-02 Normal 180 Day Track
S015 2002-10-03 Normal 180 Day Track
S014 2002-06-03 Normal 180 Day Track
S013 2002-05-13 30-day Notice
S012 2002-03-12 30-day Notice
S011 2002-02-07 30-day Notice
S010 2001-11-16 Normal 180 Day Track
S009 2001-11-14 135 Review Track For 30-day Notice
S008 2001-10-26 Real-time Process
S007 2001-10-15 Normal 180 Day Track
S006 2001-09-04 30-day Notice
S005 2001-08-13 30-day Notice
S004 2001-06-08 Normal 180 Day Track
S003 2001-04-04 Normal 180 Day Track
S002 2000-12-19 Normal 180 Day Track
S001 2000-07-28 Normal 180 Day Track

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