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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.
 
DeviceSOFTLENS66 TORIC (ALPHAFILCON A) VISIBILITY TINTED CONTACT LENS
Generic NameLenses, soft contact, extended wear
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP960022
Supplement NumberS004
Date Received02/06/2004
Decision Date03/04/2004
Product Codes LPL LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADDITION OF AN AUTOMATED INSPECTION PROCESS FOR THE SOFTLENS66.
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