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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.
 
DeviceIOPTEX PMMA ANTERIOR CHAMBER IOLS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantAdvanced Medical Optics, Inc.
1700 E. St. Andrew Pl.
P.O. Box 25162
Santa Ana, CA 92705
PMA NumberP880085
Supplement NumberS003
Date Received06/18/1996
Decision Date10/07/1996
Withdrawal Date08/23/2000
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REDUCTION OF THE INCUBATION TIME FOR BIOLOGICAL INDICATORS USED IN STERILITY TESTING
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