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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPTIGUIDE PHOTODYNAMIC THERAPY FIBER OPTIC TREATMENT SYSTEM
Generic NameSYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY
ApplicantPinnacle Biologics, Inc.
2801 Lakeside Drive. Suite 210
Bannockburn, IL 60015
PMA NumberP940010
Supplement NumberS009
Date Received04/17/2000
Decision Date09/29/2000
Product Code MVG 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
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.
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