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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 NameVISIAN ICL
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Supplement NumberS019
Date Received12/23/2010
Decision Date05/05/2011
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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