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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 NameAMVISC & AMVISC PLUS
Classification Nameaid, surgical, viscoelastic
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP810025
Supplement NumberS028
Date Received06/21/2010
Decision Date05/15/2012
Product Code
LZP[ Registered Establishments with LZP ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
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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