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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 NameACRYSOF RESTOR APODIZED DIFFRACTIVE OPTIC POSTERIOR CHAMBER IOL
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS005
Date Received08/06/2007
Decision Date10/24/2007
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for expansion of the dioptric range of the referenced models from 10. 0d to 30. 0d to 6. 0d to 30. 0d. The device models, as modified, will be marketed under the trade name acrysof restor apodized diffractive optic posterior chamber intraocular lens (iol), models sa60d3, sn60d3, ma60d3 and mn60d3, and are indicated for the visual correction of aphakia secondary to removal of a cataractous lens in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. These lenses are intended for placement in the capsular bag.
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