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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 NameQUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
Classification Namesystem, laser, photodynamic therapy
Generic Namediode laser
ApplicantVALEANT PHARMACEUTICALS LUXEMBOURG S.A.R.L.
PMA NumberP050026
Date Received07/14/2005
Decision Date04/04/2006
Product Code
MVF[ Registered Establishments with MVF ]
Docket Number 06M-0162
Notice Date 04/18/2006
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 quantel activis laser and zsl30 act, zsl120 act, and hsbmbq act slit lamp adapters. The device is indicated for the photoactivation of the light activated drug visudyne (verteporfin for injection) in photodynamic therapy for the treatment of patients with predominantly classic subfoveal choroidal neovascularization due to age-related macular degeneration, pathologic myopia, or presumed ocular hystoplasmosis.
Approval Order Approval Order
Supplements: S001 
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