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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSTAAR SURGICAL ELASTIMIDE ULTRAVIOLET-ABSORBING SILICONE THREE-PIECE POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStaar Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP880091
Supplement NumberS022
Date Received04/17/2007
Decision Date05/16/2007
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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