← FDA Medical Device Classifications

Cardiac Support Mesh Wrap

NAP · Not classified · Unknown

Classification

FDA Product Code
NAP
Device class
Not classified
Regulation
Review panel
CV
Medical specialty
Unknown
Submission type
3
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

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.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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