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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.
 
DeviceSUNSOFT(METHAFILCON A)SOFT(HYDROPHILIC)EXTENDED WEAR CONTACT LENS
Classification Namelenses, soft contact, extended wear
Generic Namelenses, soft contact, extended wear
Regulation Number886.5925
Applicant
COOPER VISION, INC.
6150 stoneridge mall road
suite 370
pleasanton, CA 94588
PMA NumberP850077
Supplement NumberS023
Date Received04/16/1997
Decision Date05/19/1997
Product Code
LPM[ Registered Establishments with LPM ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
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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