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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 INTRAOCULAR LENSES (TIER A SUBMISSION)
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantMENTOR OPHTHALMICS, INC.
PMA NumberP830056
Supplement NumberS078
Date Received07/23/1996
Decision Date01/29/1998
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 lenses models c440z, u211m, uv91f, uv91f2, u691f, u691f2, c440u, c421f5, and c451f5. These lenses are intended to be used for primary implantation for the visula correction of aphakia in patients 50 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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