PMA supplement
P910054 S009: Inoue-Balloon Catheter
FDA PMA supplement · 135 Review Track For 30-Day Notice · Toray Industries (America), Inc.
Key facts
| Original PMA | P910054 |
|---|---|
| Supplement number | S009 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Inoue-Balloon Catheter |
| Generic name | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
| Applicant | Toray Industries (America), Inc. |
| Product code | MAD |
| Received date | Oct 31, 2023 |
| Decision date | May 24, 2024 |
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: