Definition: To Correct Annular Dilatation And/or Maintain Annular Geometry Of The Aortic Valve.
| Device Type ID | 981 |
| Device Name | Aortic Annuloplasty Ring |
| Physical State | A Three Dimensional Crown Or Waveform Shaped Ring. |
| Technical Method | A Solid Or Compliant Ring Attached To The Aortic Annulus. |
| Target Area | Aortic Valve. |
| Regulation Description | Annuloplasty Ring. |
| 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 | 870.3800 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PST |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 981 |
| Device | Aortic Annuloplasty Ring |
| Product Code | PST |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Annuloplasty Ring. |
| CFR Regulation Number | 870.3800 [🔎] |
| Device Problems | |
|---|---|
Migration Or Expulsion Of Device | 1 |
| Total Device Problems | 1 |