PMA P990021S003
- Device
- PHOTOFRIN 630 PDT LASER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S003
- Product code
- MVF
- Decision date
- 2016-06-28
- Classification
- System, Laser, Photodynamic Therapy
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- Approval for the PHOTOFRIN 630 PDT Laser manufactured by Modulight, Inc located in Tampere, Finland.
Current openFDA PMA Record#
- Device
- PHOTOFRIN 630 PDT LASER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S003
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2016-06-28
- Decision code
- APPR
- Date received
- 2015-10-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the PHOTOFRIN 630 PDT Laser manufactured by Modulight, Inc located in Tampere, Finland.