SENOGRAPHE DS & 2000D FFDM SYSTEM
FDA premarket approval P990066/S022 · decided 2005-10-17
Approval details
- PMA number
- P990066
- Supplement
- S022
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE DS & 2000D FFDM SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2005-09-13
- Decision date
- 2005-10-17
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL TO ADD LABELING ALERTING USER THAT IMAGES MAY BE DISPLAYED IN A MANNER DIFFERENT FROM THAT SPECIFIED IN MQSA REQUIREMENTS.
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