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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 NumberS001
Date Received02/02/1987
Decision Date05/08/1987
Product Code HPX 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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