PMA P840064S083
- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S083
- Product code
- LZP
- Decision date
- 2023-12-18
- Classification
- Ophthalmic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- to update sodium hyaluronate (NaHy) raw material test methods
Current openFDA PMA Record#
- Device
- VISCOAT™ Ophthalmic Viscosurgical Device, DUOVISC™ Ophthalmic Viscosurgical System, DISCOVISC™ Ophthalmic Viscosurgical
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S083
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2023-12-18
- Decision code
- OK30
- Date received
- 2023-11-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update sodium hyaluronate (NaHy) raw material test methods