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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
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namesystem, laser, fiber optic, photodynamic therapy
Applicant
COOK ENDOSCOPY
4900 bethania station rd.
winston-salem, NC 27105
PMA NumberP020021
Date Received05/31/2002
Decision Date08/01/2003
Withdrawal Date 08/17/2009
Product Code
MVG[ Registered Establishments with 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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