Pericardial Patch To Facilitate Revision Surgeries
Medical specialty
Cardiovascular
Device class
2
Regulation number
870.3470
Review panel
CV
Implant
Y
Life sustaining/supporting
Y
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible
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.