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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 LASER AND VISULINK PDT ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
ApplicantCARL ZEISS MEDITEC INC
PMA NumberP990048
Supplement NumberS002
Date Received03/09/2001
Decision Date07/03/2001
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
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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