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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.
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namelens,contact(rigid gas permeable)-extended wear
Regulation Number886.5916
269 a ballardvale street
wilmington, MA 01887
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/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress