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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.
 
DeviceBAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP980006
Supplement NumberS011
Date Received08/20/2007
Decision Date09/19/2007
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE RAW MATERIAL SPECIFICATION FOR ONE OF THE COMPONENTS IN THE POLYMER FORMULATION FOR THE CONTACT LENS MATERIAL BALAFILCON A.
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