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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 POSTERRIOR CHAMBER INTRAOCULAR LENS (PCIOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP090022
Supplement NumberS013
Date Received07/24/2012
Decision Date08/16/2012
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING THAT ENHANCES THE SAFETY IN THE USE OF THE DEVICE.
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