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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
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantIOLTECH, S.A.
64 SCHOOSETT STREET
PENBROKE, MA 02359-1882
PMA NumberP960036
Supplement NumberS001
Date Received08/23/1999
Decision Date08/25/2000
Withdrawal Date 10/12/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
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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