SENOGRAPHE DS FFDM SYSTEM
FDA premarket approval P990066/S023 · decided 2006-05-05
Approval details
- PMA number
- P990066
- Supplement
- S023
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE DS FFDM SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2006-04-17
- Decision date
- 2006-05-05
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL TO CORRECT A SCALE RULE ANNOTATION ON PRINTED DIGITAL MAMMOGRAPHY IMAGES AND CORRESPONDING LABELING CHANGES TO THE OPERATOR INSTRUCTIONS.
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