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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 NameANTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameanterior chamber intraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP880087
Supplement NumberS006
Date Received08/09/1995
Decision Date12/13/1995
Product Code
HQL[ Registered Establishments with HQL ]
Docket Number n
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 steriliztion process including aeratio time and the establishment of the biological indicator incubation time.
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