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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 COLLAMER UV ¿ ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Namelens, intraocular, phakic
Generic Namephakic intraocular lens for myopic correction
ApplicantSTAAR SURGICAL CO.
PMA NumberP030016
Supplement NumberS010
Date Received08/06/2008
Decision Date09/04/2008
Product Code
MTA[ Registered Establishments with MTA ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change to the model of silicone/teflon septa currently used to manufacture collamer¿ lenses at the nidau, switzerland facility.
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