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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 (PCIOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS020
Date Received03/18/2014
Decision Date06/16/2014
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT00963742
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ALLOW FOR THE DISTRIBUTION OF AN ALTERNATE PACKAGING OF THE PRE-LOADED INJECTOR (PLI) TIPS IN A 12-PACK CARTON.
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