DeviceClearance

Product code OMH— Cardiovascular

MACROPORE CARDIO-WRAP (TS)

Classification name
Pericardial Patch To Facilitate Revision Surgeries
Device class
Class 2
Regulation
21 CFR 870.3470
Advisory panel
Cardiovascular
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code OMH under 21 CFR 870.3470, via openFDA

Market context for product code OMH

FDA has cleared 1 device under product code OMH, all in 2003, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code OMH

Recent clearances under product code OMH

Data sourced from openFDA. This site is unofficial and independent of the FDA.