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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceACRYSOF IQ TORIC INTRAOCULAR LENSES
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES, INC.
6201 SOUTH FREEWAY DR.
FORT WORTH, TX 76134
PMA NumberP930014
Supplement NumberS046
Date Received10/19/2010
Decision Date11/23/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
SOFTWARE MODIFICATION TO THE MANUAL LONG (LOW DIOPTER) WET ABERROMETER.
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