PMA P990066S017
- Device
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S017
- Product code
- MUE
- Decision date
- 2004-06-07
- Classification
- Full Field Digital, System, X-ray, Mammographic
- Generic name
- Full field digital, system, x-ray, mammographic
- Approval order statement
- APPROVAL FOR A NAME CHANGE FOR THE SENOGRAPHE 2100D FFDM SYSTEM TO THE SENOGRAPHE DS FFDM SYSTEM.
Current openFDA PMA Record#
- Device
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Applicant
- GE Healthcare
- PMA number
- P990066
- Supplement
- S017
- Product code
- MUE
- Generic name
- Full field digital, system, x-ray, mammographic
- Decision date
- 2004-06-07
- Decision code
- APPR
- Date received
- 2004-04-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A NAME CHANGE FOR THE SENOGRAPHE 2100D FFDM SYSTEM TO THE SENOGRAPHE DS FFDM SYSTEM.