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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.
 
DeviceMODEL 809A POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 E. ST. ANDREW PLACE
P.O. BOX 25162
SANTA ANA, CA 92705-4933
PMA NumberP810055
Supplement NumberS070
Date Received06/23/1998
Decision Date07/15/1998
Withdrawal Date 04/15/2009
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new test method and specification for ethylene oxide residuals prior to product release.
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