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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceClearVisc Ophthalmic Viscosurgical Device (OVD)
Generic NameAID, SURGICAL, VISCOELASTIC
Regulation Number886.4275
ApplicantBausch Health
400 Somerset Corporate Boulevard
Bridgewater, NJ 08807
PMA NumberP200025
Date Received04/20/2020
Decision Date03/23/2021
Product Code LZP 
Advisory Committee Ophthalmic
Clinical TrialsNCT03511638
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the ClearVisc Ophthalmic Viscosurgical Device (OVD). ClearVisc 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
Supplements:  
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