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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.
Classification Namelens, contact (polymethylmethacrylate)
Generic Namelens, contact (polymethylmethacrylate)
11460 johns creek parkway
duluth, GA 30097
PMA NumberP890020
Supplement NumberS001
Date Received09/29/1989
Decision Date12/28/1990
Product Code
HPX[ Registered Establishments with HPX ]
Docket Number 91M-0013
Notice Date 12/28/1990
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No