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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 INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP090022
Supplement NumberS008
Date Received08/29/2011
Decision Date09/28/2011
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
REMOVAL OF TWO MANUFACTURING PROCESS STEPS IN ORDER TO MAKE THE IOL MANUFACTURING PROCESS MORE EFFICIENT.
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