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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSILSOFT (ELASTOFILCON A) CONTACT LENSES
Classification Namelens, contact (polymethylmethacrylate)
Generic Namesoft contact lens
ApplicantBAUSCH & LOMB, INC.
PMA NumberP850068
Supplement NumberS006
Date Received11/05/1990
Decision Date11/15/1991
Product Code
HPX[ Registered Establishments with HPX ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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