- Device
- SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface
- Applicant
- Delphinus Medical Technologies
- PMA number
- P200040
- Supplement
- S001
- Product code
- PAA
- Generic name
- Automated breast ultrasound
- Decision date
- 2024-04-11
- Decision code
- APPR
- Date received
- 2023-05-30
- 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 change to Delphinus Medical Technologies, Inc., 45525 Grand River Ave, Suite 100, Novi, MI 48374-1308.