MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM

FDA premarket approval P960009/S027 · decided 2003-12-16

Approval details

PMA number

P960009

Supplement

S027

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM

Generic name

Stimulator, electrical, implanted, for parkinsonian tremor

Applicant

Medtronic, Inc.

Date received

2002-08-27

Decision date

2003-12-16

Days to decision

476 days

Decision code

APPR

Product code

MHY

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTEM WHICH INCLUDES THE MODEL 7428 KINETRA NEUROSTIMULATOR, MODEL 7436 ACCESS THERAPY CONTROLLER, MODEL 8840 N'VISION PROGRAMMER, MODEL 8870 SOFTWARE APPLICATION CARD, MODEL 7459 MEMORYMOD SOFTWARE CARTRIDGE, AND MODEL 3550-09 ACCESSORY KIT. THESE ARE REVISIONS TO THE EXISTING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY ALSO KNOWN AS THE ACTIVA SYSTEM. THE MEDTRONIC KINETRA MODEL 7428 IMPLANTABLE NEUROSTIMULATION SYSTE

510(k) clearances by this applicant