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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 & LOMB PUREVISION (BALAFILCON A) SOFT CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS017
Date Received12/01/2010
Decision Date12/27/2010
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
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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