PMA P990021S004
- Device
- PHOTOFRIN 630 PDT Laser
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S004
- Product code
- MVF
- Decision date
- 2018-01-17
- Classification
- System, Laser, Photodynamic Therapy
- Generic name
- System, laser, photodynamic therapy
- Approval order statement
- Approval for the PHOTOFRIN 630 PDT Laser to be manufactured by UnionMed Tech, Inc. Bridgewater, New Jersey.
Current openFDA PMA Record#
- Device
- PHOTOFRIN 630 PDT Laser
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P990021
- Supplement
- S004
- Product code
- MVF
- Generic name
- System, laser, photodynamic therapy
- Decision date
- 2018-01-17
- Decision code
- APPR
- Date received
- 2017-08-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the PHOTOFRIN 630 PDT Laser to be manufactured by UnionMed Tech, Inc. Bridgewater, New Jersey.