Product code NAP

Device name
Cardiac Support Mesh Wrap
Medical specialty
Unknown
Device class
N
Review panel
CV
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
Definition
The device is a passive mesh wrap that is placed around both ventricles of the heart; The intention is to inhibit further dilatation of the ventricles and thus to facilitate reverse remodeling of the myocardium. The device is indicated for use in adult patients diagnosed with dilated cardiomyopathy who are symptomatic in spite of optimal medical therapy. The device can be used alone or in conjunction with mitral valve repair or replacement, if the later therapy is judged appropriate.
Source
FDA openFDA device classification dataset