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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.
 
DevicePRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
Applicant
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP940013
Supplement NumberS007
Date Received05/10/2001
Decision Date10/04/2001
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate manufacturing facilities located at ciba vision corporation, atlanta, georgia and ciba vision batam, batam island, indonesia.
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