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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 POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantLENSTEC, INC.
PMA NumberP090022
Supplement NumberS005
Date Received07/26/2011
Decision Date09/22/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to amend the approved labeling to allow for the use of the asico softip injection system, model number as-9300 with the softec hd, softec i and softec hd ps intraocular lenses (iols).
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