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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 IQ TORIC IOLS
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
PMA NumberP930014
Supplement NumberS077
Date Received12/19/2014
Decision Date02/17/2015
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement osb
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the following changes to the post-approval study for the device: update the targeted number of subjects to be implanted from 415 to 400.
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