PMA
P890043: SIMPSON CORONARY ATHEROCATH(TM)
FDA PMA · CATHETER, CORONARY, ATHERECTOMY · Abbott Vascular
Key facts
| PMA number | P890043 |
|---|---|
| Trade name | SIMPSON CORONARY ATHEROCATH(TM) |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Abbott Vascular |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MCX |
| Approval date | Sep 14, 1990 |
| Docket number | 90M-0318 |
| Notice date | Oct 19, 1990 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Dec 11, 2006 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- Yes Withdrawn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: