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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
Classification Namelens, contact (polymethylmethacrylate)
Generic Namelens, contact (polymethylmethacrylate)
Applicant
Bausch & Lomb, Inc.
14853 deveau place
minnetonka, MN 55345
PMA NumberP850068
Supplement NumberS002
Date Received06/19/1987
Decision Date09/11/1990
Product Code
HPX[ Registered Establishments with HPX ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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