SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P080003/S003 · decided 2016-07-07
Approval details
- PMA number
- P080003
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2016-03-30
- Decision date
- 2016-07-07
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for the 30 projection tomosynthesis feature.
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