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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLI61AO LENS
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
Applicant
BAUSCH & LOMB
50 technology drive
irvine, CA 92618
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 - indications/instructions/shelf life/tradename
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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