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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.
 
DeviceWEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantCiba Vision Care
11460 Johns Creek Pkwy.
Duluth, GA 30136
PMA NumberP810005
Supplement NumberS025
Date Received11/02/1989
Decision Date03/21/1991
APCB Date05/26/2009
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
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