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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 postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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