PMA
P020030: STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · MicroPort CRM S.r.l.
Key facts
| PMA number | P020030 |
|---|---|
| Trade name | STELID II/STELIX/STELIX II ENDOCARDIAL PACING LEAD |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | MicroPort CRM S.r.l. |
| Owner/operator | MicroPort CRM S.R.L. |
| Product code | NVN |
| Approval date | Jun 17, 2004 |
| Docket number | 04M-0310 |
| Notice date | Jul 16, 2004 |
| Establishment registration | 1000165971 |
| FEI number | 1000165971 |
At a glance
- 10–99 Supplements
- Oct 2, 2013 Latest supplement decision
- No Withdrawn
- Yes 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: