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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.
 
DeviceMENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
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
Supplement NumberS002
Date Received11/28/2001
Decision Date07/12/2002
Product Code MWL 
Docket Number 02M-0335
Notice Date 08/06/2002
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 MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. THIS DEVICE IS INDICATED FOR: MENICON Z (TISILFOCON A) SPHERICAL, ASPHERIC, NON-PRISM BALLAST TORIC AND NON-PRISM BALLAST MULTIFOCAL LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 30 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PROFESSIONAL) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEASED EYES. THE LENS MAY BE PRESCRIBED IN SPHERICAL AND ASPHERIC POWERS RANGING FROM -25.00 D TO +25.00 D FOR DAILY WEAR AND -25.00 D TO +8.00 D FOR UP TO 30 DAYS EXTENDED WEAR. TORIC LENSES ARE DESIGNED TO CORRECT UP TO 5.00 D OF ASTIGMATISM AND MULTIFOCAL LENSES TO PROVIDE UP TO +3.00 D OF READING ADD POWER FOR UP TO 30 DAYS EXTENDED WEAR. THE LENS MAY BE DISINFECTED USING A CHEMICAL DISINFECTION SYSTEM ONLY. (THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS WAS CLEARED FOR DAILY WEAR UNDER K962006, K970019 AND K972443).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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