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 detector subsystem for approval of a new application specific integrated circuit (asic), and also the necessary changes to some of the detector pcb hardware, detector embedded software and detector firmware in order to support dual sourcing.
Device | Selenia Dimensions / 3Dimensions |
Classification Name | Digital Breast Tomosynthesis |
Generic Name | Digital Breast Tomosynthesis |
Applicant | HOLOGIC, INC. |
Date Received | 2018-05-02 |
Decision Date | 2018-06-22 |
PMA | P080003 |
Supplement | S007 |
Product Code | OTE |
Advisory Committee | Radiology |
Supplement Type | Real-time Process |
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 |