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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 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 - other
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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