PMA P810025S043
- Device
- Amvisc Ophthalmic Viscosurgical Device, Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S043
- Product code
- LZP
- Decision date
- 2021-08-27
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Changes of the Sodium Hyaluronate release specifications to align with the European Pharmacopoeia.
Current openFDA PMA Record#
- Device
- Amvisc Ophthalmic Viscosurgical Device, Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S043
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-08-27
- Decision code
- OK30
- Date received
- 2021-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes of the Sodium Hyaluronate release specifications to align with the European Pharmacopoeia.