Permanent Defibrillator Electrodes
The Permanent Defibrillator Electrode is an implantable lead used with compatible implantable cardioverter defibrillators (ICDs) and cardiac rhythm therapy-defibrillators (CRT-D) to sense cardiac rhythm and deliver high-energy electrical therapy when tachyarrhythmia is detected, with some transvenous models also capable of pacing the right ventricle. As an FDA Class 3 device requiring Premarket Approval (PMA), it is subject to the highest regulatory standard. The product code is NVY, reviewed by the Cardiovascular panel, and is flagged as both an implant and life-sustaining given its critical role in preventing sudden cardiac death.
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Basic Information
- Product Code
- NVY
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.
FEI Numbers
This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.