Envision Mammography Platform
FDA premarket approval P080003/S011 · decided 2025-11-24
Approval details
- PMA number
- P080003
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Envision Mammography Platform
- Generic name
- Digital breast tomosynthesis
- Applicant
- Hologic, Inc.
- Date received
- 2025-10-24
- Decision date
- 2025-11-24
- Days to decision
- 31 days
- Decision code
- APPR
- Product code
- OTE
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for a manufacturing site located at Hologic, Inc., 600 Technology Drive, Newark, DE 19702-2463.
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| Aptima CMV Quant Assay (K243935) | Hologic, Inc. | 2025-01-17 |
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