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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 INTRACULAR LENS
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS008
Date Received03/18/2011
Decision Date04/29/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type135 review track for 30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement the proposed change to the bioburden testing for the akreos posterior chamber intraocular lens.
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