PMA P010025S010
- Device
- HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S010
- Product code
- MUE
- Decision date
- 2007-06-01
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BLEMISHED PIXEL SPECIFICATIONS.
Current openFDA PMA Record#
- Device
- HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S010
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2007-06-01
- Decision code
- APPR
- Date received
- 2007-03-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BLEMISHED PIXEL SPECIFICATIONS.