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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 NumberS041
Date Received07/06/1998
Decision Date05/20/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the DuraSoft(R) 3 UV (phemfilcon A) Spherical and Optifit Toric Clear, Handling Tint, Colors, and Color Complements Soft (hydrophilic) Contact Lens (lathe cut) for Extended Wear to incorporate the pigment carbazole violet as a handling tint at Wesley Jessen - Cidra Operation, Road 173, KM 1.1, Cidra, PR 00739. The pigment will be incorporated as an in-monomer tint by entrapment.