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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 NameCOHERENT OPAL PHOTOACTIVATOR
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser
ApplicantLUMENIS
PMA NumberP990049
Supplement NumberS001
Date Received08/16/2000
Decision Date09/27/2001
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revision of the indication for use statement to read "for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia or presumed ocular histoplasmosis. ".
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