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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 NameMEMORY LENS ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantCIBA VISION CORPORATION
PMA NumberP960036
Supplement NumberS004
Date Received09/18/2000
Decision Date03/16/2001
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 for the change of the vial material from glass to plastic for the memory lens(r) iol.
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