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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 NumberS019
Date Received11/03/1995
Decision Date10/07/1997
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the current maximum level of ethylene oxide residual from "not to exceed 25 ppm" to "not to exceed 1. 0 ug/lens. ".
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