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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 NameBIOCURVE SOFT EW (METHAFILCON A) HYDROPHILIC CONTACT LENSES
Classification Namelenses, soft contact, extended wear
Generic Namecontact lenses
Regulation Number886.5925
ApplicantCAL BIONICS
PMA NumberP860040
Supplement NumberS015
Date Received05/19/1998
Decision Date03/04/1999
Product Code
LPM
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a toric configuration of the biocurve soft fw (methafilcon a) contact lens (clear and handling tint). The device, as modified, will be marketed under the trade name biocurve soft toric fw (methafilcon a) contact lens and is indicated for daily wear or extended wear by not-aphakic persons with non-diseased eyes. The lenses are for the correct of refractive ametropia (myopia, hyperopia, and astigmatism). The spherical lens may be worn by persons with up to 1. 50 diopters of astigmatism that does not interfere with visual acuity; the toric lens corrects astigmatism of 5 diopters or less. Lenses prescribed for extended wear may be worn from 1 to 7 days between removals for cleaning, rinsing, and disinfection or replacement, as recommended by the eyecare practitioner. The lenses may be disinfected using a chemical disinfection system only.
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