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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 ELASTIC/ELASTIMIDE & ELASTIC TORIC ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStaar Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP880091
Supplement NumberS028
Date Received07/23/2008
Decision Date09/10/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING.
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