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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceWIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
Generic NameSystem, laser, fiber optic, photodynamic therapy
ApplicantCook Endoscopy
4900 Bethania Station Rd.
Winstrom-Salem, NC 27105
PMA NumberP020021
Date Received05/31/2002
Decision Date08/01/2003
Withdrawal Date08/17/2009
Product Code MVG 
Docket Number 04M-0495
Notice Date 11/12/2004
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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