Pulse Generator, Permanent, Implantable
The Permanent Implantable Pulse Generator is a cardiac device intended as a permanent implant to deliver pacing pulses and other pacing therapies through leads implanted in the heart, used to treat bradyarrhythmias and other rhythm disorders requiring long-term cardiac pacing. As an FDA Class 3 device requiring Premarket Approval (PMA), it is subject to the most stringent regulatory oversight. The product code is NVZ, reviewed by the Cardiovascular panel, and is flagged as both an implant and life-sustaining due to its role as a permanent cardiac pacemaker.
Basic Information
- Product Code
- NVZ
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
Definition
Intended as a permanent implant to deliver pacing pulses and other pacing therapies through pacing leads implanted in the heart.
FEI Numbers
This FDA classification entry is associated with 35 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 35 registration numbers. Click on an entry to view related FDA registrations.