MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM

FDA premarket approval P960009/S007 · decided 2002-01-14

Approval details

PMA number

P960009

Supplement

S007

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM

Generic name

Stimulator, electrical, implanted, for parkinsonian symptoms

Applicant

Medtronic, Inc.

Date received

1999-09-30

Decision date

2002-01-14

Days to decision

837 days

Decision code

APPR

Product code

NHL

Advisory committee

Neurology

Expedited review

No

Location

Minneapolis, MN

Statement

APPROVAL FOR THE MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY WHICH INCLUDES THE MODEL 3387 DBS LEAD, MODEL 3389 DBS LEAD, MODEL 7482 EXTENSION, MODEL 7495 EXTENSION, MODEL 7426 SOLETRA NEUROSTIMULATOR, BURR HOLE RING AND CAP, MODEL 7432 PHYSICIAN PROGRAMMER, MODEL 7460 MEMORYMOD SOFTWARE CARTRIDGE, MODEL 7452 PATIENT MAGNET, MODEL 3625 TEST STIMULATOR, MODEL 3353/3354 LEAD FRAME KIT, AND ACCESSORIES. THE DEVICE IS INDICATED FOR BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE

510(k) clearances by this applicant