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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.
 
DeviceCOHERENT OPAL PHOTOACTIVATOR LASER SYSTEM
Classification Namesystem, laser, photodynamic therapy
Generic Namesystem, laser, photodynamic therapy
Applicant
LUMENIS
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[ 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
Approval Order Statement 
Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Supplements: S001 
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