| 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. |
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| Device | OPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES) |
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| Generic Name | SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY |
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| Applicant | Pinnacle Biologics, Inc.
2801 Lakeside Drive. Suite 210
Bannockburn, IL 60015 |
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| PMA Number | P940010 |
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| Supplement Number | S011 |
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| Date Received | 09/13/2013 |
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| Decision Date | 03/21/2014 |
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| Product Code |
MVG |
| Advisory Committee |
General & Plastic Surgery |
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| Supplement Type | Real-Time Process |
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| Supplement Reason | Change Design/Components/Specifications/Material |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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Approval Order Statement
APPROVAL FOR:1) A CHANGE IN THE MATERIAL OF THE TUBING CAP PLACED OVER THE DIFFUSER TIP FROM A POLYCARBONATEMATERIAL TO AN ETFE TUBING MATERIAL;2) THE USE OF HEAT BONDING FOR THE ETFE TUBING MATERIAL IN PLACE OF THE ADHESIVE BONDING PRESENTLY USED FOR THE TUBING CAP;3) ELIMINATION OF THE ORANGE SHEATH PRESENTLY ADDED OVER THE INACTIVE LENGTH OF THE PRESENTLYMARKETED FIBER OPTIC DIFFUSERS; AND4) MODIFICATION OF THE DIFFUSER TIP, SPECIFICALLY:A) USE OF A SILVER MIRROR TO REPLACE THE DIELECTRIC MATERIAL PRESENTLY USED;B) THE USE OF A SILICON DIFFUSER MIX BETWEEN THE END OF THE FIBER CORE AND DIELECTRIC MIRROR;C) AND THE ADDITION OF DIFFUSER SHRINK TUBING TO THE DISTAL END.THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME OPTIGUIDE FIBER OPTIC DIFFUSERDCYL 700 SERIES AND IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN(PORFIMER SODIUM) FOR INJECTION FOR: 1) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER OR PATIENTS WITH PARTIALLYOBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILYTREATED WITH ND:YAG LASER THERAPY;2) REDUCTION OF OBSTRUCTION AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLYOBSTRUCTING ENDOBRONCHIAL NONSMALL CELL LUNG CANCER (NSCLC);3) TREATMENT OF MICROINVASIVE ENDOBRONCHIAL NSCLC IN PATIENTS FOR WHOM SURGERY AND RADIOTHERAPY ARE NOT INDICATED; AND4) ABLATION OF HIGH-GRADE DYSPLASIA (HGD) IN BARRETTS ESOPHAGUS (BE) AMONG PATIENTS WHO ARE NOT CANDIDATES FOR ESOPHAGECTOMY. |
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