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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 NamePOSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantALCON LABORATORIES
PMA NumberP840060
Supplement NumberS022
Date Received02/17/1993
Decision Date02/20/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a number of tier a models. The models listed in attachment 1 are intended for both ciliary sulcus and capsular bag implantation; models lx10bd and mz40bd are intended for capsular bag implantation only.
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