Product code
NVN: Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes
FDA product code · Class III · Cardiovascular
Key facts
| Product code | NVN |
|---|---|
| Device | Drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes |
| Device class | Class III |
| Review panel | Cardiovascular |
| Submission type | PMA |
| GMP exempt | No |
| Implanted device | Yes |
| Life-sustaining or life-supporting | Yes |
| Definition | Drug eluting permanent RV or RA pacemaker electrodes are used with compatible pacemakers or implantable cardioverter defibrillators (ICD) or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart. |
At a glance
- None 510(k) clearances
- None De Novo grants
- 10–99 PMA approvals
- None HDE approvals
- 100–999 UDI devices (GUDID)
- 1,000+ MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database