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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 NameULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP880081
Supplement NumberS027
Date Received11/19/2001
Decision Date05/01/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the alternate sterilization facility located at edwards lifesciences llc, anasco, puerto rico.
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