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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 TORIC SINGLE-PIECE NATURAL INTRAOCULAR LENS (IOL) MODELS SN60T3, SN60T4 AND SN60T5
Classification Nameintraocular lens
Generic Nameintraocular lenses (iol)21 cfr 886.3600/class iii
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS016
Date Received11/14/2005
Decision Date12/16/2005
Product Code
HQL[ Registered Establishments with HQL ]
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 iol models sn60t3, sn60t4 and sn60t5. The device, as modified, will be marketed under the trade name acrysof toric single-piece natural iol and is indicated for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved spectacle independence for distance vision.
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