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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 NumberS020
Date Received11/13/1995
Decision Date03/11/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add sterilization services of tennessee (sst) as an alternate 100% eto sterilization site for iols produced in irvine, ca and anasco, pr and packaged in the single-pouch tyvek packaging configuratin currently approved under these pmas for sterilization at sterilization services of georgia(ssg).
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