Implantable Cardioverter Defibrillator (Non-Crt)
The Non-CRT Implantable Cardioverter Defibrillator (product code LWS) is a cardiac implant that continuously monitors the heart rhythm and delivers high-energy defibrillation shocks to the right ventricle (RV) to terminate life-threatening tachyarrhythmias such as ventricular fibrillation or ventricular tachycardia. It is classified as a Class 3 device requiring Premarket Approval (PMA) and is flagged as both an implant and a life-sustaining device, as it is designed to prevent sudden cardiac death. The device is reviewed under the Cardiovascular (CV) panel. No regulation number has been formally assigned.
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Basic Information
- Product Code
- LWS
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
These devices treat tachycardia (fast heartbeats) with RV defibrillation therapy as necessary.
FEI Numbers
This FDA classification entry is associated with 51 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 51 registration numbers. Click on an entry to view related FDA registrations.