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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 NameSOFTEC HD POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
PMA NumberP090022
Supplement NumberS013
Date Received07/24/2012
Decision Date08/16/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the directions for use to include a warning that enhances the safety in the use of the device.
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