- Device
- PROVISC Ophthalmic Viscosurgical Device
- Applicant
- Alcon Research, Ltd.
- PMA number
- P890047
- Supplement
- S055
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-09-16
- Decision code
- OK30
- Date received
- 2020-08-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adding Lifecore as an additional release testing site for raw materials and primary packaging components used in the manufacturing process of VISCOAT, PROVISC and DUOVISC.