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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 NameACRYSOF SINGLE-PIECE FOLDABLE ACRYLIC POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS006
Date Received12/14/1998
Decision Date09/20/1999
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the acrysof(r) single-piece foldable acrylic posterior chamber iol, model sa30el.
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