- Device
- VISCOAT Ophthalmic Viscoelastic System, DUOVISC Ophthalmic Viscoelastic System (consists of PRIVSC and VISCOAT)
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S074
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-03-03
- Decision code
- OK30
- Date received
- 2021-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduction of Lifecore Biomedical, LLC Site 2 as a additional quality control laboratory for release and stability chemistry testing of the VISCOAT and PROVISC Ophthalmic Viscosurgical Devices, as well as the DUOVISC Ophthalmic Viscoelastic System.