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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
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