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.
Approval for siemens own image processing algorithms on the mammomat novationdr full field digital mammography system.
| Device | SIEMENS MAMMOMAT NOVATION FULL-FIELD DIGITAL MAMMOGRAPHY (FFDM) SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTION |
| Date Received | 2009-07-22 |
| Decision Date | 2010-10-06 |
| PMA | P030010 |
| Supplement | S005 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SIEMENS MEDICAL SOLUTION 51 Valley Stream Pkwy. malvern, PA 19355 |
| 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 |