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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 RESTOR IOLS +3.0 D & +4.0 D ADD POWERS
Classification Namelens, multifocal intraocular
Generic Name21 cfr 886.3600 intraocular lens(iol)
Regulation Number886.3600
ApplicantALCON RESEARCH, LTD.
PMA NumberP040020
Supplement NumberS015
Date Received04/02/2009
Decision Date05/28/2009
Product Code
MFK[ Registered Establishments with MFK ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an expansion of the dioptric range to include 6. 0 to 9. 5 diopters in ½ diopter increments for models sn6ad1, mn6ad1 and sn6ad3.
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