SELENIA DIMENSIONS (2D) FFDM SYSTEM
FDA premarket approval P010025/S013 · decided 2008-12-22
Approval details
- PMA number
- P010025
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SELENIA DIMENSIONS (2D) FFDM SYSTEM
- Generic name
- Full field digital, system, x-ray, mammographic
- Applicant
- Hologic, Inc.
- Date received
- 2008-04-30
- Decision date
- 2008-12-22
- Days to decision
- 236 days
- Decision code
- APPR
- Product code
- MUE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Danbury, CT
- Statement
- APPROVAL FOR THE SELENIA DIMENSIONS (2D) FFDM SYSTEM.
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