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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 Name5ODEL SI-11NB UV ABSORBING SILICONE POSTERIOR IOL
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantALLERGAN MEDICAL OPTICS
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: sterilizer
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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