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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameCV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameposterior chamber intraocular lens
Regulation Number886.3600
ApplicantIOLTECH, S.A.
PMA NumberP960036
Supplement NumberS007
Date Received07/08/2002
Decision Date07/26/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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