StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
FDA premarket approval P220009 · decided 2023-02-22
Approval details
- PMA number
- P220009
- Trade name
- StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Bausch Health Companies, Inc.
- Date received
- 2022-07-07
- Decision date
- 2023-02-22
- Days to decision
- 230 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bridgewater, NJ
- 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).
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