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 |
Supplemental Filings
| 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 |
NIH GUDID Devices