Definition: To Repair Or Replace Chordae Tendinae.
| Device Type ID | 1002 |
| Device Name | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Physical State | Nonabsorbable Expanded Polytetrafluoroethylene (ePTFE) Surgical Suture Is A Monofilament, Nonabsorbable, Sterile, Flexible Thread Prepared From EPTFE And Is Intended For Use In Repair Or Replacement Of Chordae Tendinae. It May Be Undyed Or Dyed With |
| Technical Method | Provides Tension Between The Papilary Muscles And Valve Leaflets To Prevent Valve Leaflet Prolapse By Restoring Natural Function Of The Chordae Tendinae. |
| Target Area | Mitral And Tricuspid Valve Apparatus. |
| Regulation Description | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture. |
| Regulation Medical Specialty | General & Plastic Surgery |
| 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 | 878.5035 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PAW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1002 |
| Device | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement |
| Product Code | PAW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture. |
| CFR Regulation Number | 878.5035 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ON-X LIFE TECHNOLOGIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Disconnection | 1 |
Failure To Adhere Or Bond | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | On-X Life Technologies, Inc. | II | Jan-20-2017 |