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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.
 
DeviceLENSTEC SOFTEC HD PCIOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS014
Date Received08/27/2012
Decision Date09/20/2012
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT00963742
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
INCLUSION OF TWO ADDITIONAL STEAM STERILIZER UNITS FOR THE STERILIZATION OF THE FIRM'S SOFTEC SERIES OF IOLS.
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