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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMVISC(R)
Classification Nameaid, surgical, viscoelastic
Generic Namesodium hyaluronate
Regulation Number886.4275
ApplicantBAUSCH & LOMB, INC.
PMA NumberP810025
Date Received05/28/1981
Decision Date10/18/1983
Product Code
LZP[ Registered Establishments with LZP ]
Docket Number 83M-0374
Notice Date 11/28/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S015 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 S031 S032 S033 
S034 
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