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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 NamePURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS002
Date Received09/01/1999
Decision Date11/23/1999
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) adding a contraindication for the use of allergan ultracare disinfecting system to the product labeling (package insert/fitting guide and patient information booklet for frequent replacement wear); 2) removing references to thermal disinfection in the product labeling (package insert and patient information booklets); and 3) adding "the bausch & lomb(r) purevision(tm) (balafilcon a) visibility tinted contact lenses are manufactured by a cast-molding process and are surface treated by the performa(tm) surface treatment process which transforms hydrophobic silicone to hydrophilic silicate" to the description section of the package insert/fitting guide.
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