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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.
 
Trade NameSOFTEC HD INTRAOCULAR LENS (IOL), SOFTEC I IOL, SOFTEC HD PS IOL
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
PMA NumberP090022
Supplement NumberS008
Date Received08/29/2011
Decision Date09/28/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of two manufacturing process steps in order to make the iol manufacturing process more efficient.
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