PHOTOFRIN 630 PDT Laser
FDA premarket approval P990021/S005 · decided 2022-03-02
Approval details
- PMA number
- P990021
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PHOTOFRIN 630 PDT Laser
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2021-04-27
- Decision date
- 2022-03-02
- Days to decision
- 309 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- 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.
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