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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 NameSOFLEX POSTERIOR CHAMBER INTRAOCULAR LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
PMA NumberP910061
Supplement NumberS016
Date Received04/03/2008
Decision Date05/02/2008
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 limulus amebocyte lysate (lal) testing method and a change in the site for the lal final product testing to bausch & lomb, inc. ?s clearwater, florida facility.
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