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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
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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