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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 NameZIRCONIA SILICATE BEAD IOL TUMBLE POLISHING
Classification Nameintraocular lens
Generic Nameiris fixation iol
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP800049
Supplement NumberS006
Date Received01/31/1995
Decision Date07/24/1995
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 the reduction in biological indicator incubation time from 7 to 5 days.
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