OMH

Pericardial Patch To Facilitate Revision Surgeries

Product code

OMH

Device name

Pericardial Patch To Facilitate Revision Surgeries

Device class

Class 2

21 CFR

21 CFR 870.3470

Medical specialty

Cardiovascular

Marketing pathway

510(K)

Flag

Implant

Flag

Life-sustaining / life-supporting

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).