PMA P010025S015
- Device
- HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S015
- Product code
- MUE
- Decision date
- 2009-03-16
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR A CHANGE TO THE IMAGE IMPLANT DETECTION PROCESS.
Current openFDA PMA Record#
- Device
- HOLOGIC SELENIA FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S015
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2009-03-16
- Decision code
- APPR
- Date received
- 2009-02-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE IMAGE IMPLANT DETECTION PROCESS.