PHOTOFRIN 630 PDT Laser
FDA premarket approval P990021/S004 · decided 2018-01-17
Approval details
- PMA number
- P990021
- Supplement
- S004
- 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
- 2017-08-02
- Decision date
- 2018-01-17
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Bannockburn, IL
- Statement
- Approval for the PHOTOFRIN 630 PDT Laser to be manufactured by UnionMed Tech, Inc. Bridgewater, New Jersey.
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