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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 NameSTAAR SURGICAL IMPLANTABLE COLLAMER LENSES FOR MYOPIA
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Supplement NumberS020
Date Received04/04/2011
Decision Date05/04/2011
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification to the blocking process for the manufacture of the product lines.
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