|
Device | MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE |
Generic Name | Stimulator, electrical, implanted, for parkinsonian symptoms |
Applicant | MEDTRONIC Inc. 7000 CENTRAL AVENUE NE MINNEAPOLIS, MN 55432-3576 |
PMA Number | P960009 |
Supplement Number | S229 |
Date Received | 05/21/2015 |
Decision Date | 11/17/2015 |
Product Code |
NHL |
Advisory Committee |
Neurology |
Clinical Trials | NCT00354133
|
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MODIFICATION TO THE INDICATION FOR USE (IFU) FOR THE MEDTRONIC DEEP BRAIN STIMULATION (BDS) THERAPY FOR PARKINSON¿S DISEASE AND CORRESPONDING LABELING CHANGES ASSOCIATED WITH THE IFU MODIFICATION. BILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN) USING MEDTRONIC DBS THERAPY FOR PARKINSON'S DISEASE IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS IN INDIVIDUALS WITH LEVODOPA-RESPONSIVE PARKINSON'S DISEASE OF AT LEAST 4 YEARS¿ DURATION THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION. |