System, Laser, Fiber Optic, Photodynamic Therapy
Basic Information
- Device Name
- System, Laser, Fiber Optic, Photodynamic Therapy
- Trade Name
- OPTIGUIDE(TM) CYLINDRICAL FIBER OPTIC
- PMA Number
- P940010
- Supplement Number
- S005
- Device Class
- FDA Class 3
- Product Code
- MVG
- Generic Name
- SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY
- Medical Specialty
- Unknown
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- November 23, 1998
- Date Received
- August 21, 1998
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MVG | System, Laser, Fiber Optic, Photodynamic Therapy | FDA class 3 | Unknown |