PMA
P130012: MYOPORE SUTURELESS MYOCARDIAL PACING LEAD
FDA PMA · Permanent pacemaker Electrode · Great Batch Medical
Key facts
| PMA number | P130012 |
|---|---|
| Trade name | MYOPORE SUTURELESS MYOCARDIAL PACING LEAD |
| Generic name | Permanent pacemaker Electrode |
| Applicant | Great Batch Medical |
| Owner/operator | GREATBATCH MEDICAL |
| Product code | DTB |
| Approval date | Apr 30, 2015 |
| Docket number | 15M-1557 |
| Notice date | May 8, 2015 |
| Establishment registration | 2183787 |
| FEI number | 2183787 |
At a glance
- 10–99 Supplements
- Apr 19, 2024 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- No Withdrawn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: