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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 NameTIER A UV-ABSORBING POSTERIOR CHAMBER INTARA. LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantSTORZ OPHTHALMICS, INC.
PMA NumberP840039
Supplement NumberS030
Date Received08/19/1991
Decision Date02/07/1996
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 the addition of d & c green no. 6 dye to the haptics of the single-piece polymethylmethacrylate (pmma) iols under this pma and manufactured from pmma supplied from the st. Louis facility.
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