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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.
 
DeviceB&L 58(TM) (ETAFILCONA) CONTACT LENS
Generic NameLenses, soft contact, daily wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
14853 DEVEAU PLACE
MINNETONKA, MN 55345
PMA NumberP850039
Supplement NumberS003
Date Received06/19/1987
Decision Date09/11/1990
Withdrawal Date 11/18/2009
Product Code LPL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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