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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.
 
DeviceMODIFIED LABELING FOR IOL 60 MOS.STERILITY EXPIR.
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantEyetech, LLC
7016 6th St. N.
Oakdale, MN 55128
PMA NumberP880082
Supplement NumberS014
Date Received03/05/1992
Decision Date05/15/1992
Product Code HQL 
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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