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 |