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 the 30 projection tomosynthesis feature.
| Device | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
| Classification Name | Digital Breast Tomosynthesis |
| Generic Name | Digital Breast Tomosynthesis |
| Applicant | HOLOGIC, INC. |
| Date Received | 2016-03-30 |
| Decision Date | 2016-07-07 |
| PMA | P080003 |
| Supplement | S003 |
| Product Code | OTE |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 15420045508033 | P080003 | 000 |
| 15420045510760 | P080003 | 000 |
| 15420045510593 | P080003 | 000 |
| 15420045510586 | P080003 | 000 |
| 15420045510579 | P080003 | 000 |
| 15420045510562 | P080003 | 000 |
| 15420045510555 | P080003 | 000 |
| 15420045510548 | P080003 | 000 |
| 15420045510784 | P080003 | 000 |
| 15420045510777 | P080003 | 000 |
| 15420045510753 | P080003 | 000 |
| 15420045510616 | P080003 | 000 |
| 15420045512689 | P080003 | 000 |
| 15420045512696 | P080003 | 000 |
| 15420045512474 | P080003 | 000 |
| 15420045508026 | P080003 | 000 |
| 15420045508019 | P080003 | 000 |
| 15420045507296 | P080003 | 000 |
| 15420045507289 | P080003 | 000 |
| 15420045507272 | P080003 | 000 |
| 15420045510524 | P080003 | 000 |
| 15420045500013 | P080003 | 000 |
| 15420045510395 | P080003 | 000 |
| 15420045512313 | P080003 | 000 |
| 15420045511897 | P080003 | 000 |
| 15420045510388 | P080003 | 000 |
| 15420045500020 | P080003 | 001 |
| 15420045508026 | P080003 | 004 |
| 15420045512474 | P080003 | 008 |