PMA
P880055: CORONARY BALLOON DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Boston Scientific Corp
Key facts
| PMA number | P880055 |
|---|---|
| Trade name | CORONARY BALLOON DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LOX |
| Approval date | Sep 26, 1990 |
| Docket number | 90M-0437 |
| Notice date | Jan 16, 1991 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 1–9 Supplements
- Jul 19, 1991 Latest supplement decision
- Yes Withdrawn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: