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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 INTROCULAR LENSES
Classification Nameintraocular lens
Generic Nameintraocular lenses
Regulation Number886.3600
ApplicantMENTOR OPHTHALMICS, INC.
PMA NumberP830056
Supplement NumberS075
Date Received06/17/1994
Decision Date04/02/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for models c420p, c540u, c445f, c840u, u240f0, c540mc, u211f, and u241fo posterior chamber intraocular lenses as tier a modifications of clinically studied partent lenses.
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