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 labeling changes.
| Device | MAMMOMAT NOVATION DR |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTION |
| Date Received | 2009-05-18 |
| Decision Date | 2009-06-04 |
| PMA | P030010 |
| Supplement | S004 |
| Product Code | MUE |
| Advisory Committee | Radiology |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |