SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
FDA premarket approval P990066/S026 · decided 2007-01-03
Approval details
- PMA number
- P990066
- Supplement
- S026
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SENOGRAPHE DS AND ESSENTIAL FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2006-12-01
- Decision date
- 2007-01-03
- Days to decision
- 33 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- APPROVAL FOR MODIFICATIONS TO THE LABELING REGARDING THE PLACEMENT OF THE LATERALITY AND VIEW MARKER THAT FDA APPROVED UNDER P990066/S022.
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