Pericardial Patch To Facilitate Revision Surgeries

Device Code: 951

Product Code(s): OMH

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 Classification Information

Device Type ID951
Device NamePericardial Patch To Facilitate Revision Surgeries
Physical StateSheet Or Film
Technical MethodSurgical Implant
Target AreaCardiac Structures
Regulation DescriptionIntracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene.
Regulation Medical SpecialtyCardiovascular
Review PanelCardiovascular
Premarket Review Office Of Device Evaluation (ODE)
Division Of Cardiovascular Devices (DCD)
Vascular Surgery Devices Branch (VSDB)
Submission Type510(k)
CFR Regulation Number870.3470 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeOMH
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID951
DevicePericardial Patch To Facilitate Revision Surgeries
Product CodeOMH
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionIntracardiac Patch Or Pledget Made Of Polypropylene, Polyethylene Terephthalate, Or Polytetrafluoroethylene.
CFR Regulation Number870.3470 [🔎]
TPLC Last Update: 2019-04-02 19:45:22

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