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 |