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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 NameLI61AO LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
PMA NumberP910061
Supplement NumberS015
Date Received08/30/2006
Decision Date12/06/2006
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add a statement to the directions for use that the sofport model li61 ao iol has prolate aspheric surfaces and is designed to be free of spherical aberrations, and to add a figure with the modulation transfer functions for the li61ao and li61se lenses.
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