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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceBAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 N. Goodman St.
Rochester, NY 14609
PMA NumberP980006
Supplement NumberS022
Date Received04/14/2014
Decision Date07/11/2014
Product Code 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 ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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