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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Nametisilfocon a rigid gas permeable contact lens
Regulation Number886.5916
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
Supplements: S001 S002 S003 S004