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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 PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI
Classification Namelenses, soft contact, extended wear
Generic Namebalafilcon a visibility tinted contact lens
Regulation Number886.5925
ApplicantBAUSCH & LOMB, INC.
PMA NumberP980006
Supplement NumberS022
Date Received04/14/2014
Decision Date07/11/2014
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the addition of the following private label trade names: equate monthly single vision (balafilcon a) contact lens, equate monthly multi-focal (balafilcon a) contact lens, equate monthly toric (balafilcon a) contact lenses, and c-vue addvantage multifocal (balafilcon a) visibility tinted contact lenses. The device, as modified, will be marketed under the trade name the equate monthly single vision (balafilcon a) contact lens and is indicated for daily wear or extended wear from 1 to 30 days between removals, for cleaning and disinfection or disposal of the lens, as recommended by the eye care professional. 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. The lens may be prescribed for frequent/planned replacement wear or disposable wear in spherical powers ranging from +8. 00d to -20. 00d when prescribed for up to 30 days of extended wear and from +20. 00d to -20. 00d for daily wear or extended wear up to 7 days. For further information please refer to the approval order.
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