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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/VERISYSE PHAKIC IOL
Classification Namelens, intraocular, phakic
Generic Nameuv-absorbing anterior chamber phakic intraocular lens
ApplicantOPHTEC BV
PMA NumberP030028
Supplement NumberS001
Date Received11/25/2009
Decision Date11/09/2011
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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