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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 INTROCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP090022
Supplement NumberS002
Date Received07/02/2010
Decision Date08/13/2010
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO AMEND THE APPROVED LABELING FOR THE SOFTEC HD IOL TO ALLOW FOR THE USE OF THE MEDICEL VISCOJECT 1.8, MODEL# LP604350 WITH THE SOFTEC HD AND SOFTEC I IOLS.
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