| Proprietary Name: |
CONFIENT RF1 HE IS-1; CONFIENT RF1 HE IS-1 AV; Diagnostic Restoration Tool for PRIZM DR/HE and PRIZM VR/HE; ENERGEN DR DF1; ENERGEN DR IS4; ENERGEN VR DF1; ENERGEN VR IS4; INCEPTA VR IS4; LATITUDE Communicator Inductive; LATITUDE G2 Communicator; Programmer Recorder Monitor (PRM) System ZOOM; Programmer Software Application; PUNCTUA DR DF1; PUNCTUA DR IS4; PUNCTUA VR DF1; PUNCTUA VR IS4; Quick Profiles Disk; TELIGEN HE DR DF1; TELIGEN HE DR IS4; TELIGEN HE VR DF1; TELIGEN HE VR IS4; VENTAK AV; VENTAK AV II DDD; VENTAK AV II DR; VENTAK AV III DR; VENTAK PRIZM VR/DR; VENTAK VR; VITALITY 2 DR / DR EL; VITALITY 2 VR / VR EL; VITALITY DR; VITALITY DS; VITALITY DS/VR; VITALITY HE; VITALITY VR; VITALITY+ DR |
| Classification Name: |
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) |
| Product Code: |
LWP |
| Device Class: |
3 |
| Registered Establishment Name: |
Boston Scientific Corporation
|
| Registered Establishment Number: |
9616693
|
| Owner/Operator: |
Boston Scientific Corporation |
| Owner/Operator Number: |
9912058
|
| Establishment Operations: |
Manufacturer
|