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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 NATURAL IOL MODELS SN60D3 AND MN60D3
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS001
Date Received07/12/2005
Decision Date07/29/2005
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for acrysof restor natural intraocular lens (iol) models sn60d3 and mn60d3 (level a modification: addition of chromophore). The device, as modified, will be marketed under the trade name acrysof restor natural iol and is indicated for primary implantation for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with or without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. The lens is intended to be placed in the capsular bag.
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