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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(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantCIBA VISION CORPORATION
PMA NumberP960036
Supplement NumberS003
Date Received08/31/2000
Decision Date09/25/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the european phase-in study described in supplement 2 dated 8/25/00 for the memory lens(r).
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