OMH · Class II · 21 CFR 870.3470

FDA Product Code OMH: Pericardial Patch To Facilitate Revision Surgeries

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.

1
Total
1
Cleared
86d
Avg days
2003
Since

FDA 510(k) Cleared Pericardial Patch To Facilitate Revision Surgeries Devices (Product Code OMH)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OMH - Regulatory Context