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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 690 PLUS LASER & VISULINK PDT/U ADAPTER
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
ApplicantCARL ZEISS MEDITEC AG
PMA NumberP990048
Supplement NumberS003
Date Received04/22/2008
Decision Date10/31/2008
Product Code
MVF[ Registered Establishments with MVF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes to the laser controller; the addition of new user interface including touch-sensitieve screen and rotary knobs; a new integrated power supply with micro-controller electronic components; new labeling; and new software (firmware). The device, as modified, will be marketed under the trade name visulas 690plus and visulink pdt/u adapter and is indicated for use in visudyne therapy as sources of photoactivation of visudyne (verteporfin for injection) 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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