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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 ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameiol's
Regulation Number886.3600
ApplicantSTARR SURGICAL CO.
PMA NumberP880091
Supplement NumberS022
Date Received04/17/2007
Decision Date05/16/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of the rotlex iola plus optical test systems as an additional measuring system for the diopteric power measurement of 3-piece silicone intraocular lenses (iol) has been reviewed.
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