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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.
 
Trade NameFRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
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.
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