PMA
P910031: ORACLE(TM) CORONARY BALLOON DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Abbott Vascular Devices
Key facts
| PMA number | P910031 |
|---|---|
| Trade name | ORACLE(TM) CORONARY BALLOON DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular Devices |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LOX |
| Approval date | Sep 30, 1994 |
| Docket number | 94M-0402 |
| Notice date | Dec 15, 1994 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Aug 26, 2009 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- No Withdrawn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: