PMA
P120017: MODEL 5071 LEAD
FDA PMA · Permanent pacemaker Electrode · Medtronic, Inc.
Key facts
| PMA number | P120017 |
|---|---|
| Trade name | MODEL 5071 LEAD |
| Generic name | Permanent pacemaker Electrode |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | DTB |
| Approval date | Apr 27, 2015 |
| Docket number | 15M-1461 |
| Notice date | May 8, 2015 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 10–99 Supplements
- Apr 15, 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- No Withdrawn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: