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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 NameBAUSCH & LOMB SOFLENS TORIC & SOFLENS66 (ALPHAFICON A) VISIBILITY TINTED CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Supplement NumberS006
Date Received05/17/2010
Decision Date06/16/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new supplier of crosslinking material.
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