Definition: Deploys EPTFE Suture, Labeled For Use As Artificial Chordae Tendinae, While The Heart Is Beating As An Alternative To The Conventional Surgical Approach For This Type Of Mitral Valve Repair.
| Device Type ID | 1078 |
| Device Name | Artificial Chordae Tendinae Delivery System |
| Physical State | Hand-held Dispenser |
| Technical Method | Manual Dispenser |
| Target Area | Cardiovascular System |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Structural Heart Devices Branch (SHDB) |
| Submission Type | Contact ODE |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PCX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1078 |
| Device | Artificial Chordae Tendinae Delivery System |
| Product Code | PCX |