PMA
P840040: MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Boston Scientific Corp
Key facts
| PMA number | P840040 |
|---|---|
| Trade name | MEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Boston Scientific Corp |
| Owner/operator | Boston Scientific Corporation |
| Product code | LOX |
| Approval date | Dec 19, 1985 |
| Docket number | 86M-0029 |
| Notice date | Feb 10, 1986 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Nov 21, 1997 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- Yes Withdrawn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: