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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 NameVISULAS 690S AND VISULINK PDT/U ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser
ApplicantCARL ZEISS, INC.
PMA NumberP990048
Supplement NumberS001
Date Received08/14/2000
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 macular degeneration, presumed ocular histoplasmosis, or pathologic myopia. ".
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