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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceZEISS VISULAS 690 LASER AND VISULINK PDT ADAPTER
Generic NameSystem, laser, photodynamic therapy
ApplicantCarl Zeiss Meditec, AG
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP990048
Date Received08/16/1999
Decision Date04/12/2000
Withdrawal Date09/11/2025
Product Code MVF 
Docket Number 00M-1300
Notice Date 04/12/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S001 S002 S003 
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