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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 NameNCRYSOF (R) UV ABSORBING INTRAOCULAR LENSES
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP930014
Supplement NumberS002
Date Received09/27/1995
Decision Date03/26/1996
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 
Alternate sterilization process including aeration and th4e establishment of the biological indicator incubation time at your huntington, west virginia site.
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