PMA
P060039: ATTAIN STARFIX MODEL 4195 LEAD
FDA PMA · Drug eluting permanent left ventricular (lv) pacemaker electrode · Medtronic, Inc.
Key facts
| PMA number | P060039 |
|---|---|
| Trade name | ATTAIN STARFIX MODEL 4195 LEAD |
| Generic name | Drug eluting permanent left ventricular (lv) pacemaker electrode |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | OJX |
| Approval date | Jun 13, 2008 |
| Docket number | 08M-0478 |
| Notice date | Aug 27, 2008 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Feb 10, 2026 Latest supplement decision
- No Withdrawn
- Yes 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: