PMA P220009
- Device
- StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch Health Companies, Inc.
- PMA number
- P220009
- Product code
- LZP
- Decision date
- 2023-02-22
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- 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).
Current openFDA PMA Record#
- Device
- StableVisc and TotalVisc Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch Health Companies, Inc.
- PMA number
- P220009
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-02-22
- Decision code
- APPR
- Date received
- 2022-07-07
- 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).