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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 VISION IMPLANTABLE COLLAMER LENS
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Supplement NumberS006
Date Received05/28/2008
Decision Date04/02/2009
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in stopper material for the collamer lens.
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