PMA supplement
P810031 S079: Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD
FDA PMA supplement · 30-Day Notice · Johnson & Johnson Surgical Vision, Inc.
Key facts
| Original PMA | P810031 |
|---|---|
| Supplement number | S079 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Healon PRO OVD, Healon5 PRO OVD, Healon GV PRO OVD |
| Generic name | AID, SURGICAL, VISCOELASTIC |
| Applicant | Johnson & Johnson Surgical Vision, Inc. |
| Product code | LZP |
| Received date | Feb 13, 2025 |
| Decision date | Mar 11, 2025 |
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: