PMA
P870036: VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Medtronics Interventional Vascular
Key facts
| PMA number | P870036 |
|---|---|
| Trade name | VERSAFLEX BUCHBINDER OMNIFLEX PTCA CATHETER SYSTEM |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronics Interventional Vascular |
| Owner/operator | Medtronic, Inc. |
| Product code | LOX |
| Approval date | Mar 25, 1988 |
| Docket number | 88M-0160 |
| Notice date | Jun 24, 1988 |
| Establishment registration | 2953200 |
| FEI number | 3001452571 |
At a glance
- 10–99 Supplements
- Nov 17, 1998 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- Yes Withdrawn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: