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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 NameSOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Supplement NumberS004
Date Received02/06/2004
Decision Date03/04/2004
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of an automated inspection process for the softlens66.
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