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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceVISULAS 690S AND VISULINK PDT/U ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
CARL ZEISS MEDITEC AG
5160 hacienda drive
dublin, CA 94568
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/instructions/shelf life/tradename
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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