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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.
 
DeviceCM(TM) LENSES
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
ADVANCED MEDICAL OPTICS, INC.
1700 e. st. andrew place
p.o. box 25162
santa ana, CA 92705-4933
PMA NumberP810055
Supplement NumberS053
Date Received04/09/1992
Decision Date08/23/1994
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
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