SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S001 · decided 2000-11-13
Approval details
- PMA number
- P990066
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE 2000 D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2000-07-28
- Decision date
- 2000-11-13
- Days to decision
- 108 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR USE OF THE REVIEW WORKSTATION FOR FINAL INTERPRETATION OF EXAMINATIONS.
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