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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.
 
DeviceAMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP810025
Supplement NumberS034
Date Received07/15/2013
Decision Date08/13/2013
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 
CHANGE IN THE EXISTING CLEAN ROOM INTO A FORMULATION ROOM.
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