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.
Addition of a supplier for the column mounted on the senographe 2000d system. There will be no impact on the manufacturing processes (assembly and testing). There are no labeling changes or design changes to the specifications of the finished device.
| Device | SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Classification Name | Full Field Digital, System, X-ray, Mammographic |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | GE Healthcare |
| Date Received | 2001-09-04 |
| Decision Date | 2001-10-01 |
| PMA | P990066 |
| Supplement | S006 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GE Healthcare 3000 N. Grandview Blvd waukesha, WI 53188 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990066 | Original 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 |