- Device
- PROVISC™ Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S058
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2022-09-13
- Decision code
- OK30
- Date received
- 2022-08-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the maximum Ethylene Oxide (EO) sterilization process parameter specifications (without change to the EO sterilization process set points or final product release specifications).