PMA P080003S003
- Device
- SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S003
- Product code
- OTE
- Decision date
- 2016-07-07
- Classification
- Digital Breast Tomosynthesis
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval for the 30 projection tomosynthesis feature.
Current openFDA PMA Record#
- Device
- SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S003
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2016-07-07
- Decision code
- APPR
- Date received
- 2016-03-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the 30 projection tomosynthesis feature.