GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S036 · decided 2010-05-27
Approval details
- PMA number
- P990066
- Supplement
- S036
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- GE HEALTHCARE SENOGRAPHE DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2010-04-27
- Decision date
- 2010-05-27
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- CHANGE IN SUPPLIER AND REPLACEMENT OF OBSOLETE COMPUTER SYSTEMS.
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