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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
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
Applicant
MENICON CO. LTD.
269 a ballardvale street
wilmington, MA 01887
PMA NumberP990018
Date Received03/18/1999
Decision Date07/11/2000
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 00M-1414
Notice Date 07/25/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
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 Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 
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