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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 POSTERIOR CHAMBER INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS003
Date Received08/08/1996
Decision Date09/04/1998
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate sterilization process using 100% ethylene oxide, as alternate microbiological monitoring system and one resterilization in the event of an "aborted cycle. ".
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