3Dimensions
FDA premarket approval P080003/S004 · decided 2017-04-20
Approval details
- PMA number
- P080003
- Supplement
- S004
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- 3Dimensions
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2017-03-30
- Decision date
- 2017-04-20
- 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 Selenia Dimensions name to 3Dimensions.
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