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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 AC-21/AC-21B ANTERIOR CHAMBER IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP860034
Supplement NumberS015
Date Received06/30/1997
Decision Date10/02/1997
Withdrawal Date11/20/2006
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., Salinas, Puerto Rico.
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