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Establishment Registration & Device Listing

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Product Code : OJX

Establishment
Name

Registration Number

Current
Registration Yr

BENCHMARK ELECTRONICS, INC.

MN/USA

2133641

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - 3650 Merlin Patient Care

Contract Manufacturer

BIOTRONIK SE & CO. KG

GERMANY

9610139

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos

Manufacturer

drug eluting permanent left ventricular (lv) pacemaker electrode - CardioMessenger; Home Monitoring; ICS 3000; Ilesto; Lumax; PSW 1203.U/1; Renamic

Manufacturer

BIOTRONIK, INC.

OR/USA

1028232

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - CardioMessenger; Home Monitoring; ICS 3000; Lumax; PSW 1203.U/1; Renamic

Repackager/Relabeler

drug eluting permanent left ventricular (lv) pacemaker electrode - CardioMessenger; Celerity; Corox; Entovis HF(-T); Evia HF(-T); Home Monitoring; ICS 3000; LV-KIT; PSW 1203.U/1; Renamic; Stratos

Repackager/Relabeler

Boston Scientific Corporation

IRELAND

9616693

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - ACUITY Spiral; Bi Directional Torque Wrench; COGNIS; CONTAK CD; CONTAK CD Software Application; CONTAK CD2; CONTAK CD2 Software Application; CONTAK RENEWAL 3; CONTAK RENEWAL 3 AVT; CONTAK RENEWAL 3 AVT HE; CONTAK RENEWAL 3 HE; CONTAK RENEWAL 3 RF; CONTAK RENEWAL 3 RF HE; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; EASYTRAK; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D DF1/IS1; ENERGEN CRT-D IS4; Externals; Finishing Wire; INCEPTA CRT-D DF1/IS1; INCEPTA CRT-D DF1/LV1; INCEPTA CRT-D IS4; Lead Cap; Lead Stability Accessory (Suture Sleeve); LIVIAN RF1 HE; LIVIAN RF1 SE; PUNCTUA CRT-D DF1/IS1; PUNCTUA CRT-D IS4; Suture Sleeve

Manufacturer

Boston Scientific Corporation

MN/USA

2124215

2013

drug eluting permanent left ventricular (lv) pacemaker electrode - ACUITY Spiral; Bi Directional Torque Wrench; COGNIS; CONTAK CD; CONTAK CD Software Application; CONTAK CD2; CONTAK CD2 Software Application; CONTAK RENEWAL 3; CONTAK RENEWAL 3 AVT; CONTAK RENEWAL 3 AVT HE; CONTAK RENEWAL 3 HE; CONTAK RENEWAL 3 RF; CONTAK RENEWAL 3 RF HE; CONTAK RENEWAL AVT Software; CONTAK RENEWAL Software Application; EASYTRAK; EASYTRAK 2; EASYTRAK 2 IS-1; EASYTRAK 3; EASYTRAK 3 IS-1; ENERGEN CRT-D DF1/IS1; ENERGEN CRT-D IS4; Externals; Finishing Wire; INCEPTA CRT-D DF1/IS1; INCEPTA CRT-D DF1/LV1; INCEPTA CRT-D IS4; Lead Cap; Lead Stability Accessory (Suture Sleeve); LIVIAN RF1 HE; LIVIAN RF1 SE; PUNCTUA CRT-D DF1/IS1; PUNCTUA CRT-D IS4; Suture Sleeve

Manufacturer

drug eluting permanent left ventricular (lv) pacemaker electrode - ACUITY STEERABLE

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