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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
1400 north goodman st.
rochester, NY 14609-3547
PMA NumberP870013
Supplement NumberS008
Date Received10/31/1995
Decision Date05/01/1996
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the following: implementation of new manufacturing processes of clear and violet haptic polymethylmethacrylate (pmma) one-piece posterior chamber lenses; the use of a new tumbling process for your three-piece lenses; and the introduction of several tier a posterior chamber lenses, models 8192, 8490b, 8492b, 8090b, 8091b, 8193b, 8491b, 8493b, 8990b, 8991b, 8093b, 8095b, 8195b, and 8594b.