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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.
 
DeviceSILICONE UV ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantStaar Surgical Co.
1911 Walker Ave.
Monrovia, CA 91016
PMA NumberP880091
Supplement NumberS025
Date Received04/02/2008
Decision Date07/29/2008
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF MODEL AQ2015A AS A LEVEL A MODIFICATION OF PARENT MODEL AQ2010.
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