NPS — Tricuspid Valve Repair Device, Percutaneously Delivered Class III

FDA Device Classification

FDA product code NPS covers "Tricuspid Valve Repair Device, Percutaneously Delivered", a Class III medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.

Classification Details

Product Code
NPS
Device Class
Class III
Regulation Number
Submission Type
Review Panel
CV
Medical Specialty
Unknown
Implant
Yes

Definition

These devices are intended to repair heart valves by methods other than that used by the classified device (annuloplasty rings). They may be placed using non-traditional techniques or other novel methods for decreasing valvular regurgitation.