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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.
 
DeviceKONTUR SOFT (METHAFILCON A) LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantKONTUR KONTACT LENS CO., INC.
642 ALFRED NOBEL DR.
HERCULES, CA 94547
PMA NumberP850078
Supplement NumberS013
Date Received07/18/1989
Decision Date01/03/1990
Withdrawal Date 04/27/2015
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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