Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes
NVN · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
NVN
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
CV
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
Y
Implant
Y
Third-party review
N
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.