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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.
 
DeviceCOHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
Generic NameSYSTEM, LASER, PHOTODYNAMIC THERAPY
ApplicantLUMENIS
3959 WEST 1820 SOUTH
SALT LAKE CITY, UT 84104
PMA NumberP990049
Date Received08/20/1999
Decision Date04/12/2000
Withdrawal Date 09/10/2010
Product Code MVF 
Docket Number 00M-1299
Notice Date 04/12/2000
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductYes
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 
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