PMA
P040012: ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM
FDA PMA · Stent, carotid · Abbott Vascular
Key facts
| PMA number | P040012 |
|---|---|
| Trade name | ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEM |
| Generic name | Stent, carotid |
| Applicant | Abbott Vascular |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NIM |
| Approval date | Aug 30, 2004 |
| Docket number | 04M-0388 |
| Notice date | Sep 3, 2004 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Oct 22, 2025 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- No Withdrawn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: