- Device
- PHOTOFRIN 630 PDT Laser
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S005
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2022-03-02
- Decision code
- APPR
- Date received
- 2021-04-27
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PI (an updated design of the currently marketed laser, the DIOMED 630 PDT Laser, Model T2USA), and B&W TEK Inc., located at 18 Shea Way, Suite 103, Newark, DE, 19713 as the new manufacturing site of the PHOTOFRIN® 630 PDT Laser, Model BWF5-630-2-PIN.