PMA P940010S002
- Device
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S002
- Product code
- MVG
- Decision date
- 1998-01-09
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.
Current openFDA PMA Record#
- Device
- OPTIGUIDE(TM) FIBER OPTIC DIFFUSER
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S002
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 1998-01-09
- Decision code
- APPR
- Date received
- 1997-02-10
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the additional indication for use for the treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated and approval to add a 2.0 cm diffuser to the DCYL Series of diffusers.