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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.
 
DeviceSILSOFT (ELASTOFILCON A) CONTACT LENSES
Generic NameLens, contact (polymethylmethacrylate)
ApplicantBausch & Lomb, Inc.
14853 DEVEAU PLACE
MINNETONKA, MN 55345
PMA NumberP850068
Supplement NumberS004
Date Received10/18/1989
Decision Date01/31/1990
Product Code HPX 
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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