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 [🔎] |