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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(TM) UV (VASURFILCON)
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantAlcon Laboratories, Inc.
6201 S. Fwy.
Fort Worth, TX 76134
PMA NumberP940013
Supplement NumberS005
Date Received04/04/1996
Decision Date10/07/1996
Withdrawal Date12/15/2014
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE TINTING OF THE DEVICE WITH AN ALTERNATE, NON-REACTIVE, LIGHT BLUE-GREEN LOCATOR TINT (D&C GREEN NO. 6, C.I. NO. 61565) USING AN IN-MONOMER TINTING PROCESS FOR THE PRECISION(TM) UN (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR
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