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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 ULTRAVIOLET ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantSTAAR SURGICAL CO.
1911 WALKER AVE.
MONROVIA, CA 91016
PMA NumberP880091
Supplement NumberS023
Date Received11/09/2007
Decision Date12/04/2007
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN THE APPROVED POLYCARBONATE PACKAGING MATERIAL THAT IS IN DIRECT CONTACT WITH THE LENS DURING STEAM STERILIZATION AND THROUGHOUT THE SHELF-LIFE OF THE LENS.
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