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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.
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
64 schoosett street
penbroke, MA 02359-1882
PMA NumberP960036
Supplement NumberS006
Date Received06/06/2002
Decision Date06/20/2002
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a trade name change of the memorylens iol. The device will be marketed under the trade name cv232 sre pre-rolled acrylic intraocular lens and is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age of older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.