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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 NameSENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Name intraocular lens
Regulation Number886.3600
ApplicantALLERGAN, INC.
PMA NumberP980040
Supplement NumberS001
Date Received03/08/2001
Decision Date04/18/2001
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acrylic sheet casting and button fabrication manufacturing processes to be performed at a. M. O. Puerto rico, inc. , anasco, puerto rico.
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