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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.
 
DeviceSOFTHERM SOL.
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantAdvanced Medical Optics, Inc.
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberN18078
Supplement NumberS042
Date Received07/31/1989
Decision Date09/14/1989
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
Predetermined Change Control Plan AuthorizedNo
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