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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
Generic NameLenses, soft contact, daily wear
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP940013
Supplement NumberS007
Date Received05/10/2001
Decision Date10/04/2001
Withdrawal Date12/15/2014
Product Codes LPL LPM MVN 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Express GMP Supplement
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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