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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 ULTRAVIOLET-ABSORBING HYDROPHILIC POSTERIOR CHAMBER (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantIoltech, S.A.
64 Schoosett St.
Penbroke, MA 02359
PMA NumberP960036
Supplement NumberS004
Date Received09/18/2000
Decision Date03/16/2001
Withdrawal Date10/12/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE CHANGE OF THE VIAL MATERIAL FROM GLASS TO PLASTIC FOR THE MEMORY LENS(R) IOL.
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