PMA
P860019: SCIMED PTCA DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Scimed Life Systems, Inc.
Key facts
| PMA number | P860019 |
|---|---|
| Trade name | SCIMED PTCA DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Scimed Life Systems, Inc. |
| Owner/operator | Boston Scientific Corporation |
| Product code | LOX |
| Approval date | Nov 28, 1986 |
| Docket number | 86M-0496 |
| Notice date | Jan 16, 1987 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 100–999 Supplements
- Mar 31, 2011 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: