SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
FDA premarket approval P990066/S012 · decided 2002-04-03
Approval details
- PMA number
- P990066
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2002-03-12
- Decision date
- 2002-04-03
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- ADDITION OF A SUPPLIER OF THE HIGH VOLTAGE (HV) TANK ELECTRONIC BOARDS. THERE WILL BE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
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