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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 AND LOMB ALPHAFILCON A HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namealphafilcon a visibility tinted contact lenses
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP960022
Supplement NumberS002
Date Received01/09/2001
Decision Date06/28/2002
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate biological indicator, the 3m attest rapid readout biological indicator, to monitor the sterilization processes and to use only the fluorescent enzyme 3 hour readout system for routine disposition of the product. The fluorescent readout system by itself will not be used to validate the sterilization processes.
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