|
Device | 3Dimensions |
Generic Name | Digital breast tomosynthesis |
Applicant | HOLOGIC, INC. 35 CROSBY DR. BEDFORD, MA 01730 |
PMA Number | P080003 |
Supplement Number | S004 |
Date Received | 03/30/2017 |
Decision Date | 04/20/2017 |
Product Code |
OTE |
Advisory Committee |
Radiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a change to the Selenia Dimensions name to 3Dimensions. |