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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nametisilfocon a rigid gas permeable contact lens
Regulation Number886.5916
ApplicantMENICON CO. LTD.
PMA NumberP990018
Supplement NumberS002
Date Received11/28/2001
Decision Date07/12/2002
Product Code
MWL[ Registered Establishments with MWL ]
Docket Number 02M-0335
Notice Date 08/06/2002
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 Order Approval Order
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