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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.
 
DevicePUREVISION(TM)(BALAFILCON A) VISIBILITY TINTED CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantBausch & Lomb, Inc.
1400 NORTH GOODMAN ST.
ROCHESTER, NY 14609-3547
PMA NumberP980006
Supplement NumberS004
Date Received05/30/2001
Decision Date11/20/2001
Product Code LPM 
Docket Number 01M-0531
Notice Date 11/29/2001
Advisory Committee Ophthalmic
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE PURE VISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS. THE DEVICE 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.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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