PMA P940010S005
- Device
- OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S005
- Product code
- MVG
- Decision date
- 1998-11-23
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order statement
- Approval for commerical distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.
Current openFDA PMA Record#
- Device
- OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S005
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 1998-11-23
- Decision code
- APPR
- Date received
- 1998-08-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for commerical distributing of the modified DCYL Cylindrical Fiber Optics which incorporate a glued diffusing tip in place of the previously approved threaded tip. The device, as modified, will be marketed under the trade name OPTIGUIDE Cylindrical Fiber Optic (DCYL2 Diffuser Series and is indicated for: palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinon of their physician, cannot be satisfactorily treated with Nd:YAG laser therapy, and treatment of microinvasive endobronchial nonsmall cell lung cancer in patients for whom surgery and radiotherapy are not indicated.