Definition: To Repair Defects, To Be Used For Patch Grafting, To Repair Tissue, And To Buttress Sutures In The Heart And Vasculature.
| Device Type ID | 980 |
| Device Name | Intracardiac Patch Or Pledget, Biologically Derived |
| Physical State | The Device Is A Biologic Tissue, Typically In The Form Of A Sheet. The Tissue May Be Decellularized Or Crosslinked, And May Be Derived From Human Or Animal Sources. |
| Technical Method | The Device Is Sutured Into The Intended Site To Repair Or Support The Native Tissue. |
| Target Area | Heart And Vasculature |
| 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) Structural Heart Devices Branch (SHDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3470 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PSQ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 980 |
| Device | Intracardiac Patch Or Pledget, Biologically Derived |
| Product Code | PSQ |
| 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 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ADMEDUS LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORMATRIX CARDIOVASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CRYOLIFE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Integrity Problem | 2 |
Material Split, Cut Or Torn | 1 |
Torn Material | 1 |
| Total Device Problems | 4 |