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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 AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS
Classification Nameaid, surgical, viscoelastic
Generic Nameaid, surgical, viscoelastic
Regulation Number886.4275
Applicant
Bausch & Lomb, Inc.
50 technology drive
irvine, CA 92618
PMA NumberP810025
Supplement NumberS021
Date Received05/10/2002
Decision Date12/03/2002
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A BUFFERED FORMULATION (PH 6.8 - 7.6) FOR AMVISC AND AMVISC PLUS SODIUM HYALURONATE VISCOELASTICS.
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