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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
1911 walker ave.
monrovia, CA 91016
PMA NumberP990013
Supplement NumberS014
Date Received11/29/2007
Decision Date01/25/2008
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for parametric lot release using existing validated steam sterilization cycles. The device, as modified, will be marketed under the trade name collamer ultraviolet-absorbing posterior chamber intraocular lens and is indicated for the visual correction of aphakia in persons 60 years of age or older in whom a cataractous lens has been removed by phacoemulsification cataract extraction. The lens is to be implanted in the posterior chamber and in the capsular bag through a tear-free capsulorhexis (circular tear anterior capsulotomy).