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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 NameENVISTA INTRAOCULAR LENS (IOL)
Classification Nameintraocular lens
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantBAUSCH & LOMB
PMA NumberP910056
Supplement NumberS011
Date Received07/24/2012
Decision Date09/04/2012
Product Code
HQL[ Registered Establishments with HQL ]
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
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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