PMA P890047S067
- Device
- PROVSIC Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S067
- Product code
- LZP
- Decision date
- 2025-02-26
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- adding two mixing vessels for the manufacturing of PROVISC™ Ophthalmic Viscosurgical Device and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs
Current openFDA PMA Record#
- Device
- PROVSIC Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S067
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2025-02-26
- Decision code
- OK30
- Date received
- 2025-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding two mixing vessels for the manufacturing of PROVISC™ Ophthalmic Viscosurgical Device and DISCOVISC™ Ophthalmic Viscosurgical Device OVDs