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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 NumberP820021
Supplement NumberS029
Date Received05/10/1996
Decision Date09/25/1996
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling (i. E. , package insert, practitioner fitting guide, and separate patient information booklets for lenses prescribed for frequent replacement wear (focus, focus toric, and newvues (vifilcon a) soft (hydrophilic) contact lenses) and disposable wear (newvues (vifilcon a) soft (hydrophilic) contact lenses). Revisions included (1)merging planned replacement and disposable wearing schedules for the lensese into one package insert and directing the package isert to the eyecare practitioner, (2)writing separate patient instructions for lenses prescribed for disposable and frequent replacement wear, (3)updating the professional fitting guide for consistency with other labeling items, and (4)bringing the labeling up-to-date with fda's current recommendations in an effort to increase consumer comprehension and compliance. The revisions do no result in changes in the devices themselves or the indications for use of the devices.