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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.
 
DeviceENVISTA INTRAOCULAR LENS (IOL)
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP910056
Supplement NumberS011
Date Received07/23/2012
Decision Date09/04/2012
Product Code HQL 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE DIRECTIONS FOR USE (DFU) TO SPECIFY THAT THE ENVISTA MX60 LENS IS APPROVED FOR USE WITH THE MEDICEL ACCUJECT 2.6 INJECTOR SET, OR OTHER INJECTOR SETS THAT SPECIFICALLY IDENTIFY THE ENVISTA MX60 LENS IN THE CLEARED LABELING.
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