FDA product code NAP: Cardiac Support Mesh Wrap
NAP is the FDA product code for cardiac support mesh wrap. It is a Not classified device, reviewed by the Cardiovascular panel. Devices under NAP reach the market by Contact FDA; FDA lists no cleared 510(k)s for it.
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.
Classification
| Field | Value |
|---|---|
| Device name | Cardiac Support Mesh Wrap |
| Device class | Not classified |
| Review panel | CV — Cardiovascular |
| Medical specialty | Unknown |
| Premarket route | Contact FDA |
| Implant | Yes |
Recalls for NAP devices
openFDA lists no recalls for product code NAP.
Frequently asked questions
What is FDA product code NAP?
NAP is the FDA product code for cardiac support mesh wrap. It is a Not classified device, reviewed by the Cardiovascular panel.
What device class is NAP?
Not classified. Typical premarket route: Contact FDA.
Next steps
- Run an FDA pathway report with predicate devices for product code NAP
- Run a recall and safety report across every NAP manufacturer
- Watch product code NAP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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