PMA P080003S004
- Device
- 3Dimensions
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S004
- Product code
- OTE
- Decision date
- 2017-04-20
- Classification
- Digital Breast Tomosynthesis
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval for a change to the Selenia Dimensions name to 3Dimensions.
Current openFDA PMA Record#
- Device
- 3Dimensions
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S004
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2017-04-20
- Decision code
- APPR
- Date received
- 2017-03-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the Selenia Dimensions name to 3Dimensions.