PMA
P910054: INOUE BALLOON CATHETER
FDA PMA · CATHETER, PERCUTANEOUS (VALVULOPLASTY) · Toray Industries (America), Inc.
Key facts
| PMA number | P910054 |
|---|---|
| Trade name | INOUE BALLOON CATHETER |
| Generic name | CATHETER, PERCUTANEOUS (VALVULOPLASTY) |
| Applicant | Toray Industries (America), Inc. |
| Owner/operator | TORAY INDUSTRIES, INC. |
| Product code | MAD |
| Approval date | Jun 28, 1994 |
| Docket number | 94M-0269 |
| Notice date | Aug 25, 1994 |
| Establishment registration | 9614758 |
| FEI number | 3002710305 |
At a glance
- 10–99 Supplements
- Jul 1, 2024 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: