PMA
P910019: IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)
FDA PMA · CATHETER, CORONARY, ATHERECTOMY · Intensive Technology, Inc.
Key facts
| PMA number | P910019 |
|---|---|
| Trade name | IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R) |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Intensive Technology, Inc. |
| Product code | MCX |
| Approval date | May 18, 1993 |
| Docket number | 93M-0209 |
| Notice date | Jul 27, 1993 |
At a glance
- 1–9 Supplements
- Dec 30, 1998 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: