SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
FDA premarket approval P810031/S054 · decided 2015-08-25
Approval details
- PMA number
- P810031
- Supplement
- S054
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)- HEALON5
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-06-11
- Decision date
- 2015-08-25
- Days to decision
- 75 days
- Decision code
- APPR
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO UPDATE THE LABELING FOR THE HEALON5® OPHTHALMIC VISCOSURGICALDEVICE (OVD) TO REMOVE THE PHYSICIAN TRAINING PROGRAM FOR NEW USERS AND TO REVISE THE PRECAUTIONS SECTION OF THE DIRECTIONS FOR USE TO ALLOW FOR OTHER OVD REMOVAL TECHNIQUES.
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