PMA supplement
P810031 S064: Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon
FDA PMA supplement · 30-Day Notice · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P810031 |
|---|---|
| Supplement number | S064 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon, Healon GV, Healon5, Healon Ultimate Dual Pack, Healon |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | LZP |
| Received date | Feb 2, 2018 |
| Decision date | Feb 27, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: