PMA P940010S015
- Device
- Optiguide Fiber Optic Diffuser
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S015
- Product code
- MVG
- Decision date
- 2018-05-18
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- Approval of shelf life for the OPTIGUIDE Fiber Optic Diffuser, DCYL 700 Cylindrical Diffuser Series for four (4) years in all sizes of the DCYL 700 Series fibers (DCYL 710, 715, 720, 725, 750).
Current openFDA PMA Record#
- Device
- Optiguide Fiber Optic Diffuser
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S015
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2018-05-18
- Decision code
- APPR
- Date received
- 2018-04-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval of shelf life for the OPTIGUIDE Fiber Optic Diffuser, DCYL 700 Cylindrical Diffuser Series for four (4) years in all sizes of the DCYL 700 Series fibers (DCYL 710, 715, 720, 725, 750).