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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.
 
Device5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ABBOTT MEDICAL OPTICS INC
1700 e. st. andrew place
santa ana, CA 92705
PMA NumberP880081
Supplement NumberS018
Date Received04/04/1995
Decision Date07/28/1995
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for single-pouch tyvek packaging of lenses produced in irvine, ca & anasco, pr, sterilzation of lenses using previously approved 100% eto sterilization cycles & a 5 year shelf life for single pouch/100% eto sterilized lenses.
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