FDA product code OMH: Pericardial Patch To Facilitate Revision Surgeries
OMH is the FDA product code for pericardial patch to facilitate revision surgeries. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel. FDA has cleared 1 510(k) submission under OMH. The average 510(k) review took 86 days (median 86).
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.
Classification
| Field | Value |
|---|---|
| Device name | Pericardial Patch To Facilitate Revision Surgeries |
| Device class | Class II |
| Regulation | 21 CFR 870.3470 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) |
| Implant | Yes |
| Life-sustaining or supporting | Yes |
Compare with all 510(k) review times · Search every OMH clearance
Top OMH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Macropore Biosurgery, Inc. | 1 | 2003-09-04 |
Most recent OMH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K031785 | Macropore Biosurgery, Inc. | MACROPORE CARDIO-WRAP (TS) | 2003-09-04 | 86 |
Recalls for OMH devices
openFDA lists no recalls for product code OMH.
Frequently asked questions
What is FDA product code OMH?
OMH is the FDA product code for pericardial patch to facilitate revision surgeries. It is a Class II device, regulated under 21 CFR 870.3470 and reviewed by the Cardiovascular panel.
What device class is OMH?
Class II, regulation 21 CFR 870.3470. Typical premarket route: 510(k).
How long does a 510(k) take for product code OMH?
Across 1 cleared submissions the average was 86 days from receipt to decision (median 86).
Which companies have the most OMH clearances?
Macropore Biosurgery, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OMH
- Run a recall and safety report across every OMH manufacturer
- Watch product code OMH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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