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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 NameAMO SENSAR SOFT ACRYLIC MONOFOCAL INTRAOCULAR LENSES (IOLS)
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantADVANCED MEDICAL OPTICS, INC.
PMA NumberP980040
Supplement NumberS011
Date Received02/20/2007
Decision Date03/22/2007
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Elimination of the relative humidity (rh) specification in the generation area in the manufacturing facility in anasco, puerto rico.
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