System, Laser, Fiber Optic, Photodynamic Therapy
Basic Information
- Device Name
- System, Laser, Fiber Optic, Photodynamic Therapy
- Trade Name
- OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
- PMA Number
- P940010
- Supplement Number
- S009
- 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
- September 29, 2000
- Date Received
- April 17, 2000
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATION OF THE OPTIGUIDE FIBER OPTIC DIFFUSE TO INCLUDE USE OF A STERILE, SINGLE USE SHEATH WITH A REUSABLE DIFFUSING FIBER OPTIC. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM, SERIES DCYL 4 AND IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN(R) (PORFIMER SODIUM) FOR INJECTION FOR THE: 1) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIANS, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY, 2) REDUCTION OF OBSTTUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER (NSCLC), 3) TREATMENT OF MICROINVASIVE ENDOBRONCHIAL NSCLC IN PATIENTS OF 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 |