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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.
 
DeviceAMVISC AND AMVISC PLUS OPHTHALMIC VISCOSURICAL DEVICE (OVD)
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP810025
Supplement NumberS033
Date Received03/21/2013
Decision Date04/24/2013
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Add an alternate site for its working cell bank manufacturer, add an alternate vitamin supplier and change sourced chemicals to usp grade.
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