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 to the operators manual which add or strengthen a contraindication, warning, precaution, or information about an adverse reaction and add or strengthen an instruction that is intended to enhance the safe use of the device.
| Device | SIEMENS MAMMOMAT NOVATIONDR FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Generic Name | Full Field Digital, System, X-ray, Mammographic |
| Applicant | SIEMENS MEDICAL SOLUTION |
| Date Received | 2005-05-20 |
| Decision Date | 2005-06-20 |
| PMA | P030010 |
| Supplement | S002 |
| 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 |