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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 NamePOLYMETHYMETHACRYLATE INTRAOCULAR LENSES
Classification Nameintraocular lens
Generic Nameanterior chamber intraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
PMA NumberP880090
Supplement NumberS027
Date Received11/02/2009
Decision Date12/02/2009
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 
Change in the biological indicator testing site from alliance medical products in irvine, california to the bausch & lomb facility in tampa, florida.
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