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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.
 
DeviceSOFTMATE SOLUTION
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantADVANCED MEDICAL OPTICS, INC.
2525 DUPONT DR.
IRVINE, CA 92612
PMA NumberN18073
Supplement NumberS024
Date Received01/27/1995
Decision Date10/31/1995
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR ALTERNATE STERILIZATION FACILITY LOCATED AT STERIGENICS (FORMERLY RADIATION STERILIZATION, INC.) 344 BONNIE CIRCLE, CORONA, CA FOR THE GAMMA IRRADIATION OF THE CONTAINER/CLOSURE COMPONENTS FOR THE ABOVE REFERENCED DEVICES
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