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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 LASER AND VISULINK PDT ADAPTER
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantCARL ZEISS MEDITEC AG
5160 Hacienda Drive
Dublin, CA 94568
PMA NumberP990048
Supplement NumberS002
Date Received03/09/2001
Decision Date07/03/2001
Product Code MVF 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS TO THE VISULINK PDT ADAPTER IN ORDER TO MAKE THE VISULAS 790S LASER COMPATIBLE WITH BOTH ZEISS AND HAAG STREIT SLIT LAMPS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME VISULINK PDT/U ADAPTER AND IS INDICATED FOR USE WITH THE VISULAS 690S LASER THERAPY AS SOURCES OF PHOTOACTIVATION OF VISUDYNE(VERTEPORFIN FOR INJECTION) FOR THE TREATMENT OF AGE-RELATED MACULAR DEGENERATION (AMD) IN PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION( CNV).
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