| Proprietary Name: |
CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos |
| Classification Name: |
PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) |
| Product Code: |
NKE |
| Device Class: |
3 |
| Registered Establishment Name: |
BIOTRONIK, INC.
|
| Registered Establishment Number: |
1028232
|
| Owner/Operator: |
BIOTRONIK, INC. |
| Owner/Operator Number: |
1028232
|
| Establishment Operations: |
Repackager/Relabeler
|
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