Tricuspid Valve Repair Device, Percutaneously Delivered
The percutaneously delivered tricuspid valve repair device is a cardiovascular implant intended to repair the tricuspid heart valve by reducing valvular regurgitation through methods other than traditional annuloplasty rings, placed using minimally invasive percutaneous techniques without open chest surgery. It is classified as FDA Class 3, the highest risk category, requiring Premarket Approval (PMA). Product code NPS carries both implant and life-sustaining flags and is reviewed by the Cardiovascular panel.
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Basic Information
- Product Code
- NPS
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- CV
- Submission Type
- 2
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.