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 selenia dimensions/3dimensions 3d system with 15 projection angles for approval of the high resolution tomosynthesis and synthesized 2d feature, smartcurve compression paddles, as well as a new linear grid for the full-field digital mammography system.
| Device | Selenia Dimensions/3Dimensions 3D System |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2017-09-15 |
| Decision Date | 2018-03-23 |
| PMA | P080003 |
| Supplement | S006 |
| Product Code | OTE |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |