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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.
 
DeviceCUSTOMEYES(TM) 45L&55L (BUFILCON A)
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCiba Vision Corporation
11460 Johns Creek Pkwy.
Duluth, GA 30097
PMA NumberP850057
Supplement NumberS005
Date Received05/15/1995
Decision Date09/22/1995
Withdrawal Date06/10/2009
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE MANUFACTURING PROCESS USING ULTRAVIOLET LIGHT INITIATOR IN THE MODIFIED CURE PROCESS FOR BUFILCON A (55% WATER) CONTACT LENSES
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