|
Device | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM |
Generic Name | Digital breast tomosynthesis |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P080003 |
Supplement Number | S003 |
Date Received | 03/30/2016 |
Decision Date | 07/07/2016 |
Product Code |
OTE |
Advisory Committee |
Radiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the 30 projection tomosynthesis feature. |