Device |
pericardial patch to facilitate revision surgeries |
Regulation Description |
Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene. |
Definition |
Pericardial patch or pledget with the secondary function of facilitating revision surgeries by providing a plane of dissection. Does not include devices whose primary purpose is to minimize the incidence or severity of adhesion formation as a result of cardiac surgery. |
Product Code | OMH |
Regulation Number |
870.3470
|
Device Class |
2
|
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