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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 HDO
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
LENSTEC, INC.
1765 commerce ave n
st. petersburg, FL 33716
PMA NumberP090022
Supplement NumberS015
Date Received01/29/2013
Decision Date02/26/2013
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADDITIONAL LENS ANALYZER.
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