PMA P010025S018
- Device
- SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S018
- Product code
- MUE
- Decision date
- 2010-03-04
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- CHANGE IN DEVICE SOFTWARE MANAGEMENT.
Current openFDA PMA Record#
- Device
- SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- Hologic, Inc.
- PMA number
- P010025
- Supplement
- S018
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2010-03-04
- Decision code
- OK30
- Date received
- 2010-02-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN DEVICE SOFTWARE MANAGEMENT.