The following Abbott product(s) conform to the applicable provisions of the Radio Equipment Directive (2014/53/EU). All supporting documentation is retained under the premises of Abbott. This declaration is issued under the sole responsibility of the manufacturer. This declaration supersedes any declaration issued previously for the same product(s).

Each document may contain the following translations: English, Bulgarian, Croatian, Czech, Danish, Dutch, Estonian, Finnish, French, German, Greek, Hungarian, Italian, Latvian, Lithuanian, Polish, Portuguese, Romanian, Slovak, Slovenian, Spanish, Swedish and Turkish.

Visit the Abbott Cardiovascular Declarations of Conformity website to view European Union Radio Equipment Directive (RED) Declarations of Conformity for Cardiovascular products.

NEUROMODULATION: CHRONIC PAIN AND MOVEMENT DISORDERS THERAPIES

External Pulse Generators: SCS, DBS And DRG (St. Jude Medical) (PDF; 712KB)

St. Jude Medical™ invisible trial system SCS EPG

St. Jude Medical™ invisible trial system DRG EPG

St. Jude Medical™ DBS EPG

External Pulse Generators: SCS, DBS And DRG (Abbott Medical) (PDF; 635KB)

St. Jude Medical™ invisible trial system SCS EPG

St. Jude Medical™ invisible trial system DRG EPG

St. Jude Medical™ DBS EPG

Implantable Pulse Generator: Eterna™ Spinal Cord Stimulation (SCS) System (Abbott Medical) (PDF; 58.7KB)

Eterna™ SCS IPG

Charger

Implantable Pulse Generators: Proclaim™ And Infinity™ (St. Jude Medical) (PDF; 625KB)

Proclaim™ 5 Elite IPG

Proclaim™ 5 IPG

Proclaim™ 7 Elite IPG

Proclaim™ 7 IPG

Proclaim™ DRG IPG

Infinity™ 5 IPG

Infinity™ 7 IPG

Implantable Pulse Generators: Proclaim™ And Infinity™ (Abbott Medical) (PDF; 624KB)

Proclaim™ 5 XR IPG

Proclaim™ 5 IPG

Proclaim™ 7 XR IPG

Proclaim™ 7 IPG

Proclaim™ DRG IPG

Infinity™ 5 IPG

Infinity™ 7 IPG

Dorsal Root Ganglion (DRG) Stimulation: Axium™ (Spinal Modulation) (PDF; 683KB)

Axium™ implantable neurostimulator kit

Axium™ trial neurostimulator kit

Axium™ clinical programmer kit

Axium™ patient programmer kit
 

Dorsal Root Ganglion (DRG) Stimulation: Axium™ (St. Jude Medical) (PDF; 320KB)

Axium™ clinical programmer kit

Axium™ patient programmer kit

Implantable Pulse Generators: Eon Mini™, Prodigy™ And Brio™ (PDF; 471KB)

Eon Mini™ rechargeable IPG

Brio™ rechargeable IPG

Prodigy MRI™ rechargeable IPG

Prodigy™ rechargeable IPG

EONC™ IPG (PDF; 441KB)

Implantable Pulse Generators: Genesis™ And Libra™ (PDF; 459KB)

Genesis™ IPG

Libra™ IPG

LibraXP™ IPG

Controllers And Programmers (PDF; 489KB)

Genesis™ programmer

Libra™ clinician programmer

Eon™ patient programmer

Brio™ clinician programmer

Brio™ patient controller

Prodigy™ patient programmer

QUIKLINK™ Controller (PDF; 337KB)

NEUROMODULATION: RADIO FREQUENCY THERAPY

NT1100™ Radiofrequency Generator (PDF; 394KB)

NT2000IX™ Radiofrequency Generator (PDF; 394KB)