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 a change to the physician labeling of the selenia dimensions 3d system and the selenia dimensions 3d system with c-view software module, to claim superior screening accuracy of 3d plus 2d imaging, where the 2d image can be either a synthesized 2d or a full field digital mammography (ffdm) image, as compared to ffdm alone, for women with dense breasts.
Device | Selenia Dimensions 3D System. |
Classification Name | Digital Breast Tomosynthesis |
Generic Name | Digital Breast Tomosynthesis |
Applicant | HOLOGIC, INC. |
Date Received | 2017-05-02 |
Decision Date | 2017-05-23 |
PMA | P080003 |
Supplement | S005 |
Product Code | OTE |
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 | HOLOGIC, INC. 35 Crosby Dr. bedford, MA 01730 |
Supplement Number | Date | Supplement Type |
---|---|---|
P080003 | Original Filing | |
S008 | 2019-04-04 | Normal 180 Day Track |
S007 | 2018-05-02 | Real-time Process |
S006 | 2017-09-15 | Normal 180 Day Track |
S005 | 2017-05-02 | Special (immediate Track) |
S004 | 2017-03-30 | Special (immediate Track) |
S003 | 2016-03-30 | Normal 180 Day Track |
S002 | ||
S001 | 2012-10-09 | Panel Track |