PMA
P960010: MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM
FDA PMA · STENT, CORONARY · Medtronics Interventional Vascular
Key facts
| PMA number | P960010 |
|---|---|
| Trade name | MEDTRONIC WIKTOR PRIME CORONARY STENT DELIVERY SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Medtronics Interventional Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | MAF |
| Approval date | Jun 27, 1997 |
| Docket number | 98M-0726 |
| Notice date | Sep 9, 1998 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 1–9 Supplements
- May 21, 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- Yes Withdrawn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: