Implantable Pulse Generator, Pacemaker (Non-Crt)
The Non-CRT Implantable Pacemaker Pulse Generator (product code LWP) is a cardiac device implanted in the chest that delivers electrical impulses to the heart to treat bradycardia (slow heartbeats) through right atrial (RA) and/or right ventricular (RV) pacing therapy as necessary. It is classified as a Class 3 device requiring Premarket Approval (PMA), and is flagged as both an implant and a life-sustaining device, reflecting the critical nature of its cardiac support function. The device is reviewed under the Cardiovascular (CV) panel. No regulation number has been formally assigned.
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Basic Information
- Product Code
- LWP
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary.
FEI Numbers
This FDA classification entry is associated with 34 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 34 registration numbers. Click on an entry to view related FDA registrations.