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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) SOFT CONTACT LENS
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP980006
Supplement NumberS017
Date Received12/01/2010
Decision Date12/27/2010
Product Code LPM 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
REDUCTION OF THE SAMPLE SIZE TESTING PHYSICAL PROPERTIES ACCEPTANCE CRITERIA DURING THE USE OF THE AUTOMATED INSPECTION SYSTEM FOR THE PUREVISION (BALAFILCON A) CONTACT LENSES. THIS CHANGE OF THE SAMPLING PLAN APPLIES ONLY TO BAUSCH & LOMB¿S WATERFORD, IRELAND FACILITY.
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