NAP — Cardiac Support Mesh Wrap Class N
FDA product code NAP covers "Cardiac Support Mesh Wrap", a Class N medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- NAP
- Device Class
- Class N
- Regulation Number
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Unknown
- Implant
- Yes
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.