HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
FDA premarket approval P810031/S027 · decided 2006-08-28
Approval details
- PMA number
- P810031
- Supplement
- S027
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- HEALON,HEALON GV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2006-04-13
- Decision date
- 2006-08-28
- Days to decision
- 137 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW SECONDARY PACKAGING CONFIGURATION FOR THE HEALON, HEALONGV AND HEALON5 SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES.
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