| Device |
implantable pulse generator, programmer and battery charger |
| Definition |
Intended for the treatment of moderate to severe heart failure. |
| Physical State |
resembles an implantable cardiac pacemaker, it differs in that it devlivers it electrical stimulation pulses during the absolute refractory period and therefore does not initiate a cardiac cycle, thus it does not regulate rhythmicity |
| Technical Method |
electricallly stimulates the heart during the absolute refractory period to improve cardiac contractile properties |
| Target Area |
apllies electrical pulses to the heart |
| Review Panel |
Cardiovascular |
|---|
| Product Code | PCW |
|---|
|
Not Classified Reason
|
For Export Only
|
|---|
| Submission Type |
Enforcement Discretion
|
|---|
| Device Class |
Not Classified
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Third Party Review |
Not Third Party Eligible |
