SENOGRAPHE ESSENTIAL SYSTEM
FDA premarket approval P990066/S024 · decided 2006-09-01
Approval details
- PMA number
- P990066
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE ESSENTIAL SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2006-08-02
- Decision date
- 2006-09-01
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL TO ADD STATEMENTS TO THE USER AND INSTALLATION INSTRUCTIONS TO CAUTION ABOUT THE EQUIPMENT THAT MAY NOT PROPERLY DISPLAY OR PRINT THE LARGER IMAGES PRODUCED BY THE SENOGRAPHE ESSENTIAL.
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