SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
FDA premarket approval P010025/S018 · decided 2010-03-04
Approval details
- PMA number
- P010025
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELENIA FFDM SYSTEM FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2010-02-03
- Decision date
- 2010-03-04
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- CHANGE IN DEVICE SOFTWARE MANAGEMENT.
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