PMA P010025S013
- Device
- SELENIA DIMENSIONS (2D) FFDM SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S013
- Product code
- MUE
- Decision date
- 2008-12-22
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR THE SELENIA DIMENSIONS (2D) FFDM SYSTEM.
Current openFDA PMA Record#
- Device
- SELENIA DIMENSIONS (2D) FFDM SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S013
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2008-12-22
- Decision code
- APPR
- Date received
- 2008-04-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE SELENIA DIMENSIONS (2D) FFDM SYSTEM.