PMA P860047S034
- Device
- OcuCoat OVD
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S034
- Product code
- LZP
- Decision date
- 2021-01-13
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval to utilize a new facility to perform analytical quality control testing of the Amvisc/Amvisc Plus and OcuCoat fill/finish products.
Current openFDA PMA Record#
- Device
- OcuCoat OVD
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S034
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2021-01-13
- Decision code
- APPR
- Date received
- 2020-06-15
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to utilize a new facility to perform analytical quality control testing of the Amvisc/Amvisc Plus and OcuCoat fill/finish products.