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. |
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Device | MENICON Z RIGID GAS PERMEABLE CONTACT LENS |
Generic Name | Lens, contact (rigid gas permeable), extended wear |
Regulation Number | 886.5916 |
Applicant | MENICON CO. LTD. 21-19, Aoi 3-Chome, Naka-ku Nagoya Aichi 460-0-0006 |
PMA Number | P990018 |
Date Received | 03/18/1999 |
Decision Date | 07/11/2000 |
Product Code |
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
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 |
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