PMA
P070012: EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM
FDA PMA · Stent, carotid · Medtronic Vascular
Key facts
| PMA number | P070012 |
|---|---|
| Trade name | EXPONENT SELF-EXPANDING CAROTID STENT SYSTEM WITH OVER-THE-WIRE OR RAPID-EXCHANGE DELIVERY SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Medtronic Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | NIM |
| Approval date | Oct 23, 2007 |
| Docket number | 07M-0411 |
| Notice date | Nov 9, 2007 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 1–9 Supplements
- Mar 6, 2008 Latest supplement decision
- Yes Withdrawn
- Yes 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: