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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 MODEL U940A 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 NumberS001
Date Received08/23/1999
Decision Date08/25/2000
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A SHELF-LIFE EXTENSION TO 18 MONTHS, A PROPOSED PROTOCOL FOR ADDITIONAL SHEL-LIFE EXTENSIONS, AND A NEW DIMENSIONAL SPECIFICATION.
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