Pulse-Generator, Single Chamber, Sensor Driven, Implantable
The Single Chamber Sensor-Driven Implantable Pulse Generator (product code LWO) is a cardiac implantable device that delivers electrical stimulation to the heart in a single chamber, with sensor-driven rate adaptation that adjusts pacing based on the patient's physiological demands. It is classified as a Class 3 device requiring Premarket Approval (PMA) due to its implantable nature and critical cardiac function. The device is flagged as an implant and is reviewed under the Cardiovascular (CV) panel. No regulation number has been formally assigned.
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Basic Information
- Product Code
- LWO
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.