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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 NamePRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP940013
Supplement NumberS007
Date Received05/10/2001
Decision Date10/04/2001
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
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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