PMA P840064S022
- Device
- VISCOAT(R) SODIUM HYALURONATE
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S022
- Product code
- LZP
- Decision date
- 2001-02-13
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE VISCOAT SOLUTION AND DUOVISC SYSTEM LABELING INSERT.
Current openFDA PMA Record#
- Device
- VISCOAT(R) SODIUM HYALURONATE
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S022
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2001-02-13
- Decision code
- APPR
- Date received
- 2000-12-15
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES THAT ADD TWO PRECAUTIONARY STATEMENTS TO THE VISCOAT SOLUTION AND DUOVISC SYSTEM LABELING INSERT.