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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 NameSILICONE POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantALLERGAN MEDICAL OPTICS
PMA NumberP880081
Supplement NumberS024
Date Received01/07/1999
Decision Date07/02/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the labeling for slm-2/uv intraocular lenses (iols) to incorporate recent findings regarding the comparative incidence of posterior capsule opacification and nd:yag capsulotomy with silicone iols approved under this pma versus polymethylmethacrylate (pmma) iols.
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