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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 E. St. Andrew Pl.
Santa Ana, CA 92705
PMA NumberP820049
Supplement NumberS064
Date Received06/30/1997
Decision Date10/02/1997
Withdrawal Date07/25/2006
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 for alternate sterilization parameters for the 100% ethylene oxide (ETO) sterilization process for IOLs sterilized at Steri-Tech, Inc., Salina, Puerto Rico.
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