PMA
P810046: SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Advanced Cardiovascular Systems, Inc.
Key facts
| PMA number | P810046 |
|---|---|
| Trade name | SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETE |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Advanced Cardiovascular Systems, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOX |
| Approval date | Mar 3, 1982 |
| Docket number | 82M-0071 |
| Notice date | Mar 26, 1982 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 100–999 Supplements
- Oct 15, 2010 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: