PHOTOFRIN 630 PDT LASER
FDA premarket approval P990021/S003 · decided 2016-06-28
Approval details
- PMA number
- P990021
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PHOTOFRIN 630 PDT LASER
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Pinnacle Biologics, Inc.
- Date received
- 2015-10-06
- Decision date
- 2016-06-28
- Days to decision
- 266 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 manufactured by Modulight, Inc located in Tampere, Finland.
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