510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OMHClass II

Pericardial Patch To Facilitate Revision Surgeries

21 CFR 870.3470 / Cardiovascular
FDA source (opens on fda.gov)

OMH is the FDA product code for Pericardial Patch To Facilitate Revision Surgeries, a class II device type, regulated under 21 CFR 870.3470. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
OMH
Device name
Pericardial Patch To Facilitate Revision Surgeries
FDA 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.
Regulation
21 CFR 870.3470
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code OMH

By decision year
1 clearance under product code OMH with a decision year between 2003 and 2003, 2003 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OMH by decision year
YearClearances
20031

Applicants with the most clearances

Product code OMH
Applicants holding the most 510(k) clearances under product code OMH
ApplicantClearances
Macropore Biosurgery, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code