- Device
- Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S040
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2020-10-01
- Decision code
- OK30
- Date received
- 2020-09-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Removal of an in-process raw material quality control test affecting the sodium hyaluronate (NaHy) raw material for the Amvisc and Amvisc Plus Ophthalmic ViscosurgicalDevices (OVDs) and change the release specification criteria for Amvisc and Amvisc Plus OVDs.