SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P990066/S006 · decided 2001-10-01
Approval details
- PMA number
- P990066
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SENOGRAPHE 2000D FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- GE Healthcare
- Date received
- 2001-09-04
- Decision date
- 2001-10-01
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Waukesha, WI
- Statement
- ADDITION OF A SUPPLIER FOR THE COLUMN MOUNTED ON THE SENOGRAPHE 2000D SYSTEM. THERE WILL BE NO IMPACT ON THE MANUFACTURING PROCESSES (ASSEMBLY AND TESTING). THERE ARE NO LABELING CHANGES OR DESIGN CHANGES TO THE SPECIFICATIONS OF THE FINISHED DEVICE.
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