• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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.
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Bausch & Lomb, Inc.
1400 north goodman st.
rochester, NY 14609-3547
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 - indications/instructions/shelf life/tradename
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 bythe 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.