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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameLENSTEC SOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
PMA NumberP090022
Date Received09/01/2009
Decision Date04/12/2010
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number 10M-0220
Notice Date 04/23/2010
Advisory Committee Ophthalmic
Clinical Trials NCT00963742
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the softec hd posterior chamber intraocular lens (pciol). The device is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.
Approval Order Approval Order
Supplements: S001 S002 S004 S005 S006 S007 S008 S009 S010 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
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