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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,SOFTEC I,SOFTEC HD PS AND SOFTEC HDO
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP090022
Supplement NumberS025
Date Received09/30/2015
Decision Date10/20/2016
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of a new raw material production method for the device molding.
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