PMA
P960013: TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · ABBOTT MEDICAL
Key facts
| PMA number | P960013 |
|---|---|
| Trade name | TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NVN |
| Approval date | Jun 20, 1997 |
| Docket number | 98M-0450 |
| Notice date | Jul 16, 1998 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: