PMA P940010S009
- Device
- OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S009
- Product code
- MVG
- Decision date
- 2000-09-29
- Classification
- System, Laser, Fiber Optic, Photodynamic Therapy
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Approval order 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.
Current openFDA PMA Record#
- Device
- OPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
- Applicant
- Pinnacle Biologics, Inc.
- PMA number
- P940010
- Supplement
- S009
- Product code
- MVG
- Generic name
- System, laser, fiber optic, photodynamic therapy
- Decision date
- 2000-09-29
- Decision code
- APPR
- Date received
- 2000-04-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.