PMA
P040038: XACT CAROTID STENT SYSTEM
FDA PMA · Stent, carotid · Abbott Vascular, Inc.
Key facts
| PMA number | P040038 |
|---|---|
| Trade name | XACT CAROTID STENT SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIM |
| Approval date | Sep 6, 2005 |
| Docket number | 05M-0381 |
| Notice date | Sep 23, 2005 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Mar 20, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 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: