- Device
- Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S042
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-07-08
- Decision code
- OK30
- Date received
- 2021-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the site of Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) Residual Testing for the Amvisc and Amvisc Plus Ophthalmic Viscosurgical Devices.