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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NamePURE VISION VISIBILITY TINTED CONTACT LENS FOR EXTENDED WEAR
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a hydrophilic contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Date Received03/06/1998
Decision Date02/05/1999
Product Code
LPM[ Registered Establishments with LPM ]
Docket Number 99M-0237
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the purevision(tm) (balafilcon a) visibility tinted contact lens. This device is indicated for daily or extended wear from 1 to 7 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care practitioner. The lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2. 00 diopters or less, that does not interfere with visual acuity.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S014 S016 S017 S019 S020 S021 
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