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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
1765 commerce ave n
st. petersburg, FL 33716
PMA NumberP090022
Supplement NumberS004
Date Received12/15/2010
Decision Date02/02/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to extend the power range for which lenses are marketed in 1/4 diopter increment from 18. 0 through 25. 0 diopters to 15. 0 through 25. 0 diopters. The device, as modified, will be marketed under the trade name softec hd ps posterior chamber intraocular lens (pciol) and is indicated for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21. The lens is indicated for capsular bag placement.