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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameARTISAN MYOPIA PHAKIC IOL
Classification Namelens, intraocular, phakic
Generic Nameuv-absorbing anterior chamber phakic intraocular lens
ApplicantOPHTEC BV
PMA NumberP030028
Supplement NumberS002
Date Received10/29/2010
Decision Date11/23/2010
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Shortening of ethylene oxide degassing phase process and the addition of an additional sterilization configuration.
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