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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.
Classification Namesystem, laser, fiber optic, photodynamic therapy
Generic Namesystem, laser, fiber optic, photodynamic therapy
5 canewood industrial park
st michael BB110
PMA NumberP940010
Supplement NumberS009
Date Received04/17/2000
Decision Date09/29/2000
Product Code
MVG[ Registered Establishments with MVG ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the optiguide fiber optic diffuse to include use of a sterile, single use sheath with a reusable diffusing fiber optic. The device, as modified, will be marketed under the trade name optiguide photodynamic therapy fiber optic treatment system, series dcyl 4 and is indicated for use in photodynamic therapy with photofrin(r) (porfimer sodium) for injection for the: 1) palliation of patients with completely obstructing esophageal cancer, or of patients with partially obstructing esophageal cancer who, in the opinion of their physicians, cannot be satisfactorily treated with nd:yag laser therapy, 2) reduction of obsttuction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (nsclc), 3) treatment of microinvasive endobronchial nsclc in patients of whom surgery and radiotherapy are not indicated.