| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | DIOMED 630 PDT LASER |
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| Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
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| Applicant | Pinnacle Biologics, Inc.
2801 Lakeside Drive. Suite 210
Bannockburn, IL 60015 |
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| PMA Number | P990021 |
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| Date Received | 05/04/1999 |
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| Decision Date | 06/30/2000 |
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| Product Code |
MVF |
| Docket Number | 00M-1387 |
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| Notice Date | 07/14/2000 |
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| Advisory Committee |
General & Plastic Surgery |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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Approval Order Statement
APPROVAL FOR THE DIOMED 630 PDT LASER, MODEL T2USA. THIS DEVICE IS INDICATED FOR USE IN PHOTODYNAMIC THERAPY WITH PHOTOFRIN (PORFIMER SODIUM) AS A SOURCE OF ACTIVATION OF PHOTOFRIN FOR: A) PALLIATION OF PATIENTS WITH COMPLETELY OBSTRUCTING ESOPHAGEAL CANCER, OR OF PATIENTS WITH PARTIALLY OBSTRUCTING ESOPHAGEAL CANCER WHO, IN THE OPINION OF THEIR PHYSICIAN, CANNOT BE SATISFACTORILY TREATED WITH ND:YAG LASER THERAPY. B) REDUCTION OF OBSTRUCTING AND PALLIATION OF SYMPTOMS IN PATIENTS WITH COMPLET |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 S003 S004 S005 |
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