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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 NameMENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantCIBA VISION CORPORATION
PMA NumberP830056
Supplement NumberS079
Date Received11/12/1998
Decision Date05/11/1999
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 posterior chamber intraocular lens models c451f, c421f, and c455a5. These lenses are intended to be used for primary implantation for the visual correction of aphakia in patients 60 years of age or older where a cataractous lens has been removed using extracapsular extraction methods. The lenses are intended to be placed in either the ciliary sulcus or capsular bag.
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