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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 NameSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
Classification Namelenses, soft contact, daily wear
Generic Namemethafilcon a soft (hydrophilic) contact lens
Regulation Number886.5925
ApplicantSUNSOFT CORP.
PMA NumberP850077
Supplement NumberS023
Date Received04/16/1997
Decision Date05/19/1997
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate molded lens manufacturing process for a multifocal lens design. The device, as modified, will be marketed under the trade name sunsoft multiples(tm) and is indicated for dialy wear or extended wear from 1 to 7 days between removals for cleaning and disinfecting as recommended by the eye care professional. The lens is indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3. 00 diopters (d) of add and who exhibit refractive astigmatism of no more than 1. 50 d that does not interfere with visual acuity. The lens ranges in spherical power from -20. 00d to +10. 00 d.
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