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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 ADAPT AO HOLDER FOLDER/M160 HOLDER/PARKER GASKET
Classification Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB, INC.
PMA NumberP060022
Supplement NumberS009
Date Received09/08/2011
Decision Date10/07/2011
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of bioburden testing of the akreos adapt ao holder folder, m160 holder, and parker gasket from a contract vendor to bausch & lomb.
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