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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.
 
DeviceSOFTEC HD POSTERIOR CHAMBER INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS004
Date Received12/15/2010
Decision Date02/02/2011
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT00963742
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO EXTEND THE POWER RANGE FOR WHICH LENSES ARE MARKETED IN 1/4 DIOPTER INCREMENT FROM 18.0 THROUGH 25.0 DIOPTERS TO 15.0 THROUGH 25.0 DIOPTERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD PS POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL) AND 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.
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