PMA P890047S061
- Device
- PROVISC™ Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S061
- Product code
- LZP
- Decision date
- 2023-08-15
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Addition of a redundant Ethylene Oxide (EO) sterilization chamber for routine sterilization of the subject ophthalmic viscosurgical devices.
Current openFDA PMA Record#
- Device
- PROVISC™ Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S061
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-08-15
- Decision code
- OK30
- Date received
- 2023-07-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a redundant Ethylene Oxide (EO) sterilization chamber for routine sterilization of the subject ophthalmic viscosurgical devices.