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
| Device Type ID | 951 |
| Device Name | Pericardial Patch To Facilitate Revision Surgeries |
| Physical State | Sheet Or Film |
| Technical Method | Surgical Implant |
| Target Area | Cardiac Structures |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Vascular Surgery Devices Branch (VSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OMH |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 951 |
| Device | Pericardial Patch To Facilitate Revision Surgeries |
| Product Code | OMH |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene. |
| CFR Regulation Number | 870.3470 [🔎] |