• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
DeviceStableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
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
Labeling Part 2