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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 NameARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
Classification Namelens, intraocular, phakic
Generic Nameuv-absorbing anterior chamber phakic intraocular lens
ApplicantOPHTEC BV
PMA NumberP030028
Date Received07/01/2003
Decision Date09/10/2004
Product Code
MTA[ Registered Establishments with MTA ]
Docket Number 05M-0026
Notice Date 01/21/2005
Advisory Committee Ophthalmic
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the artisan (model 206 and 204) phakic intraocular lens, also known as the verisyse (vrsm5us and vrsm6us) phakic intraocular lens to be distributed by advance medical optics. The device is indicated for: 1) the reduction or elimination of myopia in adults with myopia ranging from -5 to -20 diopters with less than or equal to 2. 5 diopters of astigmatism at the spectacle plane and whose eyes have an anterior chamber depth greater than or equal to 3. 2 millimeters; and, 2) patients with documented stability of refraction for the prior 6 months, as demonstrated by spherical equivalent change of less than or equal to 0. 50 diopters.
Approval Order Approval Order
Supplements: S001 S002 S003 
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