PNJ — Leadless Pacemaker Class III
FDA product code PNJ covers "Leadless Pacemaker", a Class III medical device regulated under 21 CFR 870.3610. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants.
Classification Details
- Product Code
- PNJ
- Device Class
- Class III
- Regulation Number
- 870.3610
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
Definition
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.