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.
Approval for the siemens mammomat novationdr full field digital mammography system. The device generates digital mammographic images that can be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional film-based mammographic systems. These mammographic images can be interpreted by either hardcopy film or by softcopy at a workstation.
| Device | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTION |
| Date Received | 2003-04-10 |
| Decision Date | 2004-08-20 |
| Notice Date | 2004-09-03 |
| PMA | P030010 |
| Supplement | S |
| Product Code | MUE |
| Docket Number | 04M-0387 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS MEDICAL SOLUTION 51 Valley Stream Pkwy. malvern, PA 19355 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P030010 | Original Filing | |
| S006 | 2009-10-13 | Normal 180 Day Track |
| S005 | 2009-07-22 | Normal 180 Day Track |
| S004 | 2009-05-18 | Special (immediate Track) |
| S003 | 2005-10-26 | Real-time Process |
| S002 | 2005-05-20 | Special (immediate Track) |
| S001 | 2005-01-19 | Normal 180 Day Track |