PMA
P970035: AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM
FDA PMA · STENT, CORONARY · Medtronic, Ireland
Key facts
| PMA number | P970035 |
|---|---|
| Trade name | AVE MICRO STENT II OVER-THE-WIRE CORONARY STENT SYSTEM AND AVE GFX OVER-THE-WIRE CORONARY STENT SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Medtronic, Ireland |
| Owner/operator | Medtronic, Inc. |
| Product code | MAF |
| Approval date | Dec 23, 1997 |
| Docket number | 98M-0973 |
| Establishment registration | 9612164 |
| FEI number | 3002806434 |
At a glance
- 10–99 Supplements
- Aug 30, 2007 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- Yes Withdrawn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: