PMA P810025S041
- Device
- Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S041
- Product code
- LZP
- Decision date
- 2021-04-07
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Changes to component supplier and packaging modification for rubber plunger stopper.
Current openFDA PMA Record#
- Device
- Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S041
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-04-07
- Decision code
- OK30
- Date received
- 2021-03-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to component supplier and packaging modification for rubber plunger stopper.