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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceW-55 (METHAFILCON A) AND HORIZON 55 SOFT EXTENDED WEAR CONTACT LENSES
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantWESTCON CONTACT LENS CO., INC.
611 EISENHAUER ST.
GRAND JUNCTION, CO 81505
PMA NumberP990072
Date Received11/16/1999
Decision Date08/22/2000
Withdrawal Date 06/10/2009
Product Code LPM 
Docket Number 00M-1475
Notice Date 08/31/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE HORIZON 55 EW AND HORIZON 55 EW WESTINT (METHAFILCON A) SOFT HYDROPHILIC CONTACT LENSES FOR EXTENDED WEAR (CLEAR AND VISIBILITY TINT). THESE DEVICES ARE INDICATED FOR EXTENDED WEAR FROM 1 TO 7 DAYS BETWEEN REMOVEL FOR CLEANING, RINSING AND DISINFECTING AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN NOT-APHAKIC PERSONS WITH NON DISEASED EYES THAT ARE MYOPIC OR HYPEROPIC. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 1.50 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  
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