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Device | WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER |
Generic Name | SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY |
Applicant | COOK ENDOSCOPY 4900 BETHANIA STATION RD. WINSTON-SALEM, NC 27105 |
PMA Number | P020021 |
Date Received | 05/31/2002 |
Decision Date | 08/01/2003 |
Withdrawal Date
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08/17/2009 |
Product Code |
MVG |
Docket Number | 04M-0495 |
Notice Date | 11/12/2004 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER, WHICH REQUESTED APPROVAL FOR USE WITH THE PHOTOSENSITIVE DRUG PHOTOFRIN FOR THE INDICATION FOR USE FOR ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT UNDERGO ESOPHAGECTOMY. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
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