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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceAMVISC(R)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch & Lomb, Inc.
50 Technology Drive
Irvine, CA 92618
PMA NumberP810025
Date Received05/28/1981
Decision Date10/18/1983
Product Code LZP 
Docket Number 83M-0374
Notice Date 11/28/1983
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S013 
S015  S035 S023 S024 S033 S021 S025 S022 S020 S038 S031 
S032 S034 S027 S029 S030 S028 S026 S037 S040 S041 S043 S044 
S039 S042 
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