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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 ADVANCED OPTICS ASPHERIC LENS AND AKROES AO MICRO INCISION LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS006
Date Received02/02/2010
Decision Date04/01/2010
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design modifications to model mi60l and use of medicel viscoject 2. 2 lp60430 inserter with model ao60 and is indicated for the replacement of the human crystalline lens in the visual correction of aphakia.
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