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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.
 
DeviceTHE SOFTEC HD IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS023
Date Received06/16/2014
Decision Date07/09/2014
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ADD THREE COMPONENT WASHERS FOR THE USE IN THE FINAL CLEAN AREA AND INSPECTION DEPARTMENT TO REDUCE BIOBURDEN AND ENDOTOXIN OF THE INTRAOCULAR LENSES.
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