Implantable Pulse Generator
Device Code: 1089
Product Code(s):
QFV Definition: Deliver Cardiac Contractility Modulation Signals During The Absolute Refractory Period
Device Classification Information
| Device Type ID | 1089 |
| Device Name | Implantable Pulse Generator |
| Physical State | Resembles An Implantable Cardiac Defibrillator. |
| Technical Method | Electrically Stimulates The Heart During The Absolute Refractory Period To Improve Cardiac Contractility Properties |
| Target Area | Heart |
| Review Panel | Cardiovascular |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QFV |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 1089 |
| Device | Implantable Pulse Generator |
| Product Code | QFV |
| FDA Device Classification | Class 3 Medical Device |
TPLC Last Update: 2019-04-02 19:48:14