PMA P860047
- Device
- OcuCoat 1ml syringe, OcuCoat ml syrince 6 pack, OcuCoat 2ml syringe
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S034
- Product code
- LZP
- Decision date
- 2023-05-31
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Change to an alternative syringe barrel manufacturing site used for the OcuCoat OVD.
Current openFDA PMA Record#
- Device
- OcuCoat 1ml syringe, OcuCoat ml syrince 6 pack, OcuCoat 2ml syringe
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S035
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-05-31
- Decision code
- OK30
- Date received
- 2023-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to an alternative syringe barrel manufacturing site used for the OcuCoat OVD.