- Device
- Lumicell Direct Visualization System (DVS)
- Applicant
- Lumicell, Inc.
- PMA number
- P230014
- Supplement
- S001
- Product code
- SAW
- Generic name
- Fluorescence imaging for breast cancer detection
- Decision date
- 2024-05-29
- Decision code
- OK30
- Date received
- 2024-04-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to the Lumicell Direct Visualization System (DVS), consisting of a supplier change for the mirrors and lenses of the device and the implementation of a manufacturing fixture at the finished device manufacturer to facilitate the gluing procedure for the device