PMA
P850089: CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · Medtronic Cardiac Rhythm Disease Management
Key facts
| PMA number | P850089 |
|---|---|
| Trade name | CAPSURE SP, CAPSURE, CAPSURE 2 LEADS, EXCELLENCE S, IMPULSE, IMPLUSE II EXCELLENCE SS, LEADS |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Owner/operator | Medtronic, Inc. |
| Product code | NVN |
| Approval date | Jul 29, 1986 |
| Docket number | 86M-0329 |
| Notice date | Aug 22, 1986 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Apr 15, 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- No Withdrawn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: