Selenia Dimensions 3D System.
FDA premarket approval P080003/S005 · decided 2017-05-23
Approval details
- PMA number
- P080003
- Supplement
- S005
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Selenia Dimensions 3D System.
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2017-05-02
- Decision date
- 2017-05-23
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a change to the Physician Labeling of the Selenia Dimensions 3D System and the Selenia Dimensions 3D System with C-View Software Module, to claim superior screening accuracy of 3D plus 2D imaging, where the 2D image can be either a synthesized 2D or a Full Field Digital Mammography (FFDM) image, as compared to FFDM alone, for women with dense breasts.
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