| Proprietary Name: |
Attain; Attain Bipolar OTW Lead; Attain OTW; CareLink SmartSync Percepta, Solera, Serena Application; Consulta CRT-P; Insync; Percepta CRT-P MRI SureScan; Percepta Quad CRT-P MRI SureScan; Serena CRT-P MRI SureScan; Serena Quad CRT-P MRI SureScan; Solara CRT-P MRI SureScan; Solara Quad CRT-P MRI SureScan; Syncra CRT-P; Viva CRT-P |
| Classification Name: |
PULSE GENERATOR, PERMANENT, IMPLANTABLE |
| Product Code: |
NVZ |
| Device Class: |
3 |
| Registered Establishment Name: |
Medtronic Europe Sarl
|
| Registered Establishment Number: |
9614453
|
| Premarket Submission Number: |
P010015 |
| Owner/Operator: |
Medtronic, Inc. |
| Owner/Operator Number: |
2112641
|
| Establishment Operations: |
Manufacturer; Repackager/Relabeler
|