Implantable Pulse Generator
FDA product code QFV · Class III (high risk) · Cardiovascular
Deliver Cardiac Contractility Modulation signals during the absolute refractory period
0510(k) clearances
1PMA approvals
1recalls
Implantimplanted device
PMA approvals
- P180036 OPTIMIZER Smart System · Impulse Dynamics (Usa), Inc. · 03/21/2019
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1173-2024 Class II | OPTIMIZER model CCM X11 implantable pulse generator (IPG) devices - Smart Mini and LiteOPTIMIZER devices may cease to deliver CCM therapy if the device incorrectly detects a charging error. This… | Impulse Dynamics (USA) Inc | 01/05/2024Open, Classified |