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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameOPTIGUIDE FIBER OPTIC DIFFUSER (DCYL CYLINDRICAL DIFFUSER SERIES)
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namelaser for photodynamic therapy (pdt)
ApplicantPINNACLE BIOLOGICS
PMA NumberP940010
Supplement NumberS010
Date Received06/12/2002
Decision Date08/01/2003
Product Code
MVG[ Registered Establishments with MVG ]
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for use with the photosensitive drug photofrin for the additional indication for use for the ablation of high-grade dysplasia in barrett's esophagus patients who do not undergo esophagectomy.
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