SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
FDA premarket approval P990066/S025 · decided 2006-10-20
Approval details
- PMA number
- P990066
- Supplement
- S025
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENOGRAPHE 2000D AND DS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEMS
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2006-09-27
- Decision date
- 2006-10-20
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- ADDITION OF GE HEALTHCARE/FINLAND AS AN ALTERNATE SUPPLIER FOR THE X-RAY BUCKYS USED ON THE DEVICE.
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