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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 NameAKREOS POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS002
Date Received10/24/2008
Decision Date02/18/2009
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the packaging, labeling and design of the akreos posterior chamber intraocular lens, model: akreos advanced optics aspheric intraocular lens, ao60. The device, as modified, will be marketed under the trade name akreos ao micro incision lens, model mi60l and is indicated for the replacement of the human crystalline lens in the visual correction of aphakia.
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