SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S017 · decided 2004-06-07
Approval details
- PMA number
- P990066
- Supplement
- S017
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE 2100D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2004-04-12
- Decision date
- 2004-06-07
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR A NAME CHANGE FOR THE SENOGRAPHE 2100D FFDM SYSTEM TO THE SENOGRAPHE DS FFDM SYSTEM.
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