Establishment Registration & Device Listing

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Product Code : NVN

Establishment
Name

Registration Number

Current
Registration Yr

Medtronic Singapore Operations Pte Ltd

SINGAPORE

3008973940

2013

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - Adapta, Versa, Sensia IPG; Advisa DR MRI

Manufacturer; Repackager/Relabeler

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - CapSure Bipolar Lead; CapSure Sense; CAPSURE SENSE BIPOLAR LEAD; CapSure Unipolar Lead

Manufacturer; Repackager/Relabeler

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - CapSureFix Novus Leads

Manufacturer; Repackager/Relabeler

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - CapSureFix MRI SureScan Lead; Revo MRI IPG

Manufacturer; Repackager/Relabeler

MEDTRONIC, INC.

MN/USA

2182208

2013

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - SELECTSECURE

Manufacturer; Repackager/Relabeler; Specification Developer

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - CapSure Bipolar Lead; CapSure Sense; CAPSURE SENSE BIPOLAR LEAD; CapSure Unipolar Lead

Manufacturer; Specification Developer

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - CapSure Epicardial Pacing lead

Manufacturer

Plexus Manufacturing Sdn. Bhd.

MALAYSIA

3004593495

2013

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - 2696 InCheck Patient Assistant

Contract Manufacturer

PRO-TECH DESIGN & MFG., INC.

CA/USA

2032521

2013

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes

Contract Manufacturer

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes

Contract Manufacturer

Sorin CRM SAS

FRANCE

3008159616

2013

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - Drug-eluting permanent defibrillator electrodes; Kit accessories BJF24D; Kit accessories BJF25D; Kit accessories BRF24D; Kit accessories BRF25D; Kit accessories BRF26D; Kit accessories BTF25D; Kit accessories BTF26D; Kit accessories Isoline 2CR5; Kit accessories Isoline 2CR6; Kit accessories Isoline 2CT5; Kit accessories Isoline 2CT6; kit accessory BR46D; Kit stilet Situs UW28D; Stelid II BJF24D/BJF25D; Stelid II BTF25D /BTF26D; Stelid II UTF25D/UTF26D; Stelix BR44D/BR45D/BR46D; Stelix II BRF24D/BRF25D/BRF26D

Repackager/Relabeler; Specification Developer; Complaint File Establishment

drug eluting permanent right ventricular (rv) or right atrial (ra) pacemaker electrodes - Accessory for pacemaker, ICD and CRT-D Permanent magnet; Accessory for pacemaker, ICD and CRT-D Screw driver; Defibrillation lead Isoline 2CR; Defibrillation lead Isoline 2CT; Defibrillator implantable dual chamber Paradym DR 8550; Defibrillator implantable single chamber Paradym VR 8250; Kit accessories BJF24D; Kit accessories BJF25D; Kit accessories BRF24D; Kit accessories BRF25D; Kit accessories BRF26D; Kit accessories BTF25D; Kit accessories BTF26D; Kit accessories Isoline 2CR5; Kit accessories Isoline 2CR6; Kit accessories Isoline 2CT5; Kit accessories Isoline 2CT6; kit accessory BR46D; Kit stilet Situs UW28D; Programming system for pacemaker,ICD&CRT-D CPR3 wand; Programming system for pacemaker,ICD&CRT-D Orchestra Plus

Repackager/Relabeler; Specification Developer; Complaint File Establishment

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Establishment Registration & Device Listing

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