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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMENICON Z RIGID GAS PERMEABLE CONTACT LENS
Generic NameLens, contact (rigid gas permeable), extended wear
Regulation Number886.5916
ApplicantMENICON CO. LTD.
21-19, Aoi 3-Chome, Naka-ku
Nagoya Aichi 460-0-0006
PMA NumberP990018
Date Received03/18/1999
Decision Date07/11/2000
Product Code MWL 
Docket Number 00M-1414
Notice Date 07/25/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE LENS. MENICON Z(TM) (TISILFOCON A) SPHERICAL OR ASPHERIC LENSES AND NON-PRISM BALLAST TORIC LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 7 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PRACTITIONER) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE DISINFECTED USING A...
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 
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