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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.
 
DeviceMEMORY LENS(R) UV ABSORBING HYDROPHILIC POSTERIOR CHAMBER IOL
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
IOLTECH, S.A.
64 schoosett street
penbroke, MA 02359-1882
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 report
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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