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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.
 
DeviceSOFTEE HD POSTERIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP090022
Supplement NumberS022
Date Received05/12/2014
Decision Date06/16/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO REDUCE THE SIZE OF THE SECONDARY PACKAGING WHICH HOUSES THE POUCHED INTRAOCULAR LENSES, LABEL AND DIRECTIONS FOR USE (DFU). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SOFTEC HD, SOFTEC I, AND SOFTEC HDO AND IS INDICATED FOR THE REPLACEMENT OF THE HUMAN CRYSTALLINE LENS FOLLOWING PHACOEMULSIFICATON CATARACT REMOVAL INADULTS OVER THE AGE OF 21.
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