PMA
P950001: SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · Boston Scientific
Key facts
| PMA number | P950001 |
|---|---|
| Trade name | SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285 |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | NVN |
| Approval date | May 8, 1996 |
| Docket number | 96M-0371 |
| Notice date | Oct 24, 1996 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Apr 2, 2021 Latest supplement decision
- No Withdrawn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: