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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.
 
DeviceMODELS PC-58NBM & PC-58NBZ IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
1700 EAST ST. ANDREW PL.
SANTA ANA, CA 92705
PMA NumberP820049
Supplement NumberS062
Date Received11/03/1995
Decision Date10/07/1997
Withdrawal Date 07/25/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1.0 ug/lens."
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