Selenia Dimensions/3Dimensions 3D System
FDA premarket approval P080003/S006 · decided 2018-03-23
Approval details
- PMA number
- P080003
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Selenia Dimensions/3Dimensions 3D System
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2017-09-15
- Decision date
- 2018-03-23
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- 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.
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