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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCOHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser
ApplicantLUMENIS
PMA NumberP990049
Date Received08/20/1999
Decision Date04/12/2000
Withdrawal Date 09/10/2010
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 00M-1299
Notice Date 04/12/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Approval Order Approval Order
Supplements: S001 
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