PMA P840064S066
- Device
- Ophthalmic Viscosurgical Devices
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S066
- Product code
- LZP
- Decision date
- 2017-05-18
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Approval to include a 0.85 mL volume of ProVisc OVD and make labeling changes accordingly.
Current openFDA PMA Record#
- Device
- Ophthalmic Viscosurgical Devices
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S066
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2017-05-18
- Decision code
- APPR
- Date received
- 2017-03-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to include a 0.85 mL volume of ProVisc OVD and make labeling changes accordingly.