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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
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS005
Date Received07/26/2011
Decision Date09/22/2011
Product Code HQL 
Advisory Committee Ophthalmic
Clinical TrialsNCT00963742
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO AMEND THE APPROVED LABELING TO ALLOW FOR THE USE OF THE ASICO SOFTIP INJECTION SYSTEM, MODEL NUMBER AS-9300 WITH THE SOFTEC HD, SOFTEC I AND SOFTEC HD PS INTRAOCULAR LENSES (IOLS).
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