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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 SINGLE-PIECE POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameintraocular lenses (iol)21 cfr 886.3600/class iii
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS014
Date Received04/16/2004
Decision Date04/29/2004
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the indications statement, to indicate the iols for use in adult patients following cataract surgery. Previously, the iols were indicated for use in persons 60 years of age or older when extracapsular cataract extraction or phacoemulsification are performed or where a cataractous lens has been removed. The device is indicated for the replacement of the human lens to achieve visual correction of aphakia in adults following cataract surgery.
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