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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.
 
DeviceCV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantIoltech, S.A.
64 Schoosett St.
Penbroke, MA 02359
PMA NumberP960036
Supplement NumberS007
Date Received07/08/2002
Decision Date07/26/2002
Withdrawal Date10/12/2006
Product Code HQL 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF AN ALTERNATE STEAM STERILIZER FOR THE TERMINAL STERILIZATION OF THE CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS.
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