- Device
- PROVSIC™ Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S064
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2024-06-17
- Decision code
- OK30
- Date received
- 2024-05-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to use a campaign filling strategy for the production of PROVISC™ Ophthalmic Viscosurgical Device, VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscoelastic System, and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs at the Lifecore Biomedical manufacturing site