PMA P080003
- Device
- Envision Mammography Platform
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S008
- Product code
- OTE
- Decision date
- 2025-11-24
- Classification
- Digital Breast Tomosynthesis
- Generic name
- Digital breast tomosynthesis
- Approval order statement
- Approval for a manufacturing site located at Hologic, Inc., 600 Technology Drive, Newark, DE 19702-2463.
Current openFDA PMA Record#
- Device
- Envision Mammography Platform
- Applicant
- Hologic, Inc.
- PMA number
- P080003
- Supplement
- S011
- Product code
- OTE
- Generic name
- Digital breast tomosynthesis
- Decision date
- 2025-11-24
- Decision code
- APPR
- Date received
- 2025-10-24
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Hologic, Inc., 600 Technology Drive, Newark, DE 19702-2463.