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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.
 
DeviceIOL DELIVERY SYSTEM
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
1765 COMMERCE AVE N
ST. PETERSBURG, FL 33716
PMA NumberP090022
Supplement NumberS017
Date Received05/22/2013
Decision Date07/25/2013
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A DIFFERENT DELIVERY SYSTEM, THE DEVICE WHICH HOLDS THE INTRAOCULAR LENS (IOL) IN PLACE WITHIN ITS SALINE FILLED VIAL.
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