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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceStableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch Health Companies, Inc.
400 Somerset Corporate Boulevard
Bridgewater, NJ 08807
PMA NumberP220009
Date Received07/07/2022
Decision Date02/22/2023
Product Code LZP 
Docket Number 23M-0607
Notice Date 02/24/2023
Advisory Committee Ophthalmic
Clinical TrialsNCT04192630
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the StableVisc Ophthalmic Viscosurgical Device (OVD). StableVisc is indicated for use as a surgical aid in ophthalmic anterior segment procedures including:1) Extraction of a cataract; and2) Implantation of an intraocular lens (IOL).
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements:  
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