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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 NumberS022
Date Received05/12/2014
Decision Date06/16/2014
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 reduce the size of the secondary packaging which houses the pouched intraocular lenses, label and directions for use (dfu). The device, as modified, will be marketed under the trade name softec hd, softec i, and softec hdo and is indicated for the replacement of the human crystalline lens following phacoemulsificaton cataract removal inadults over the age of 21.