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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 & AMVISC PLUS
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Dr.
Irvine, CA 92618
PMA NumberP810025
Supplement NumberS028
Date Received06/21/2010
Decision Date05/15/2012
Product Code LZP 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS.
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