- Device
- Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S044
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-06-22
- Decision code
- APPR
- Date received
- 2022-10-27
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a change in the rubber plunger stopper component of the primary packaging for the subject devices.