Tricuspid Valve Repair Device, Percutaneously Delivered

NPS · Class III — High Risk (PMA approval required, life-sustaining) · Unknown

Classification

FDA Product Code: NPS
Device class: Class III — High Risk (PMA approval required, life-sustaining)
Regulation: —
Review panel: CV
Medical specialty: Unknown
Submission type: 2
GMP exempt: N
Life sustaining: Y
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 3

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown