Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
The Drug-Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrode is an implantable lead designed for use with compatible pacemakers, implantable cardioverter defibrillators (ICDs), or cardiac rhythm therapy (CRT) devices to deliver pacing pulses to the heart, incorporating drug elution to reduce inflammation or fibrosis at the electrode-tissue interface. As an FDA Class 3 device requiring Premarket Approval (PMA), it is subject to the highest regulatory standard given its complex, life-sustaining implant function. The product code is NVN, reviewed by the Cardiovascular panel, and the device is flagged as both an implant and life-sustaining.
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Basic Information
- Product Code
- NVN
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 26 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 26 registration numbers. Click on an entry to view related FDA registrations.