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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 Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP830037
Supplement NumberS042
Date Received04/07/1999
Decision Date05/07/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following: 1) minor modification of the polymer formulation to include changes in the ratio of ingredients; 2) configuration change to include a bifocal design for the device; 3) modifications to the labeling to include the presbyopic indication and add the sentence "FreshLook(R) Lenses with UV-absorbing monomer help protect against the transmission of harmful UV radiation tot he cornea and into the eye"; 4) modification of the Note and Warning; 5) combining the package inserts for the bifocal, spherical and toric configurations; and 6) minor editorial changes to the spherical and toric indications.