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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.
 
Device8IGNATURE CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCiba Vision Corporation
11460 Johns Creek Pkwy.
Duluth, GA 30097
PMA NumberP890012
Supplement NumberS003
Date Received10/06/1994
Decision Date11/09/1994
Withdrawal Date05/12/2009
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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