Prosthesis, Mitral Valve, Percutaneously Delivered

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

Classification

FDA Product Code: NPU
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 replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 15

Source

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