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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 NameCIBA VISION (VASURFILCON A) SOFT CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lens
Regulation Number886.5925
ApplicantCIBA VISION CORPORATION
PMA NumberP940013
Supplement NumberS010
Date Received02/24/2010
Decision Date04/13/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at p. T. Ciba vision batam, batam island, indonesia for front-end processing of the device.
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