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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.
 
DeviceSILSOFT (CLASTOFILCON A) CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
14853 DEVEAU PLACE
MINNETONKA, MN 55345
PMA NumberP850068
Supplement NumberS012
Date Received09/19/2014
Decision Date10/17/2014
Product Code 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  
ADDITIONAL AUTOCLAVE FOR THE SILSOFT® (ELASTOFILCON A) CONTACT LENSES.
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